Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice
Conditions: Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
Sponsor: Pfizer

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 of 5 7  
N O N -I N T E R V E N TI O N A L ( NI) S T U D Y P R O T O C O L 
St u d y  i nf or m ati o n 
Title  
Real -W or ld St u d y of 
Ceftazi di me - Avi bacta m t o C haracterize t he 
Us age  i n Cli nical Practice  
Pr ot oc ol n u m ber  
C 3 5 9 1 0 3 7  
Pr ot oc ol versi o n i de ntifier  
Pr ot oc ol A me n d me nt 3  
D ate  
1 2  A pril  2 0 2 2  
Acti ve s u bst a nce  
ceftazi di me-a vi bacta m, A C T: J 0 1 D D 5 2  
Me dici n al pr o d uct  
Za viceft a ®  (ceftazi di me-a vi bacta m )  
Rese arc h q uesti o n a n d o bjecti ves  
T he mai n o bjecti ve of t his o bser vati o nal 
st u d y is t o descri be t he real- w orl d usa g e , 
effecti ve ness a n d micr o bi ol o gical feat ures of 
ceftazi di me-avi bacta m  i n cli nical practice i n 
C hi na. 
A ut h or (s) 
 P har m D 
Pf izer, C hi na 
; 
 M D P h D 
Pfizer, C hi na 
; 
 MSc  
P fizer, C hi na 
 
, M D M Sc  
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 of 5 7  
Pfizer, N Y H Q  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer.  E xce pt as ot her wise a gree d t o i n 
writi n g, b y acce pti n g or re vie wi n g t his d oc u me nt, y o u a gree t o h ol d t his i nf or mati o n i n c o nfi de nce a n d n ot 
c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w) or use it f or u na ut h orize d p ur p oses.  I n 
t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n otifie d. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)
P P D

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 of 5 7  
1.  T A B L E O F C O N T E N T S  
1. T A B L E O F C O N T E N T S  ....................................................................................................... 3 
LI S T O F T A B L E S  ..................................................................................................................... 6 
LI S T O F FI G U R E S  ................................................................................................................... 6 
2. LI S T O F A B B R E VI A TI O N S  ................................................................................................ 7 
3. R E S P O N SI B L E P A R TI E S  .................................................................................................... 9 
4. A B S T R A C T  ......................................................................................................................... 1 0 
5. A M E N D M E N T S A N D U P D A T E S  ..................................................................................... 1 2 
6. MI L E S T O N E S  ..................................................................................................................... 1 3 
7. R A TI O N A L E A N D B A C K G R O U N D  ................................................................................ 1 4 
8. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S  ................................................................. 1 5 
9. R E S E A R C H M E T H O D S  .................................................................................................... 1 6 
9. 1. St u d y desi g n ............................................................................................................ 1 6  
9. 1. 1. E n d p oi nts a n d esti ma n ds ............................................................................ 1 8  
9. 2. Setti n g ...................................................................................................................... 1 9  
9. 2. 1. I n cl usi o n criteria ......................................................................................... 2 0  
9. 2. 2. E xcl usi o n criteria ........................................................................................ 2 0  
9. 2. 3. St u d y p o p ulati o n ......................................................................................... 2 0  
9. 2. 4. Me dical i nf or mati o n c ollecti o n ................................................................... 2 0  
9. 2. 5. Baseli ne assess me nt .................................................................................... 2 0  
9. 2. 6. Me dical rec or d re vie w ................................................................................ 2 1  
9. 2. 7. Ce ntral la b assess me nt ................................................................................ 2 1  
9. 2. 8. Data c ollecti o n date .................................................................................... 2 1  
9. 3. Varia bles .................................................................................................................. 2 2  
9. 3. 1. D e y o- C harls o n Co m or bi dit y  I n de x ............................................................ 2 4 
9. 3. 2. A P A C H E II sc ore a n d S O F A sc ore ............................................................ 2 4  
9. 3. 3. Pitt Bactere mia Sc ore ................................................................................. 2 4  
9. 3. 4. S o urce of i nf ecti o n ...................................................................................... 2 4  
9. 3. 5. I n di cati o n .................................................................................................... 2 4  
9. 3. 6. Micr o bi ol o gical test res ult .......................................................................... 2 5  
9. 3. 7. E m piric t hera p y a n d defi niti ve t hera p y ...................................................... 2 5  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 of 5 7  
9. 3. 8. Cli nical a n d micr o bi ol o gical o utc o me e val u ati o n ...................................... 2 6  
9. 4. Data s o urces ............................................................................................................ 2 6  
9. 5. St u d y size ................................................................................................................ 2 6  
9. 6. Data ma na g e me nt  .................................................................................................... 2 7 
9. 6. 1. Case re p ort f or ms ( C R Fs)/ Data c ollecti o n t o ols ( D C Ts)/ Electr o nic 
data rec or d  ........................................................................................................ 2 7 
9. 6. 2. Rec or d r ete nti o n  .......................................................................................... 2 8 
9. 7. Data a n al ysis  .......................................................................................................... 2 8  
9. 7. 1. A nal ysis sets ............................................................................................... 2 8  
9. 7. 2. A nal ysis of t he pri mar y e n d p oi nt ............................................................... 2 9  
9. 7. 3. A nal ysis of t he sec o n dar y e n d p oi nt ............................................................ 2 9  
9. 7. 4. A nal ysis of t he c o variates ........................................................................... 3 0  
9. 8. Q ualit y c o ntr ol ......................................................................................................... 3 0  
9. 9. Li mitati o ns of t he researc h m et h o ds ....................................................................... 3 0  
9. 1 0. Ot her as pects ......................................................................................................... 3 1  
1 0. P R O T E C TI O N O F H U M A N S U BJ E C T S  ........................................................................ 3 1 
1 0. 1. Patie nt i nf or mati o n ................................................................................................ 3 1  
1 0. 2. Patie nt c o nse nt ....................................................................................................... 3 1  
1 0. 3. Patie nt wit h dra wal ................................................................................................. 3 2  
1 0. 4. I nstit uti o nal re vie w b oar d (I R B)/I n d e pe n de nt et hics c o m mittee (I E C) ................ 3 2  
1 0. 5. Et hical c o n d uct of t he st u d y .................................................................................. 3 3  
1 1.  M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S R E Q UI R E M E N T S  ...................................................................................... 3 3 
1 1. 1. Safet y re p orti n g f or pri mar y data c ollecti o n ......................................................... 3 3  
1 1. 2. Safet y re p orti n g f or sec o n dar y d ata c ollecti o n str uct ure d data a nal ysis ............... 4 1 
1 1. 3. Safet y re p orti n g f or sec o n dar y d ata c ollecti o n re q uires h u man re vie w of 
u nstr uct ure d data ....................................................................................................... 4 1  
1 1. 4. Si n gle refer e nce s af et y d oc u me nt ......................................................................... 4 2  
1 2. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S ........ 4 3 
1 3. R E F E R E N C E S  .................................................................................................................. 4 4 
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  ......................................................... 4 7 
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  ......................................... 4 8 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 of 5 7  
A N N E X 3. C RI T E RI A F O R E V A L U A TI O N O F C LI NI C A L A N D 
MI C R O BI O L O GI C A L O U T C O M E  .................................................................................. 4 9 
A N N E X 4. D E Y O -C H A R L S O N C O M O R BI DI T Y I N D E X  .................................................. 5 1 
A N N E X 5. A P A C H E II  ........................................................................................................... 5 2 
A N N E X 6. Se q ue ntial Or ga n Fail ure Assess me nt ( S O F A) Sc ore *  ........................................ 5 4 
A N N E X 7. Pitt Bacte re mia Sc ore ............................................................................................ 5 5 
A N N E X 8. D ata A bstracti o n Sc he d ule .................................................................................... 5 6  
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 6 of 5 7  
LI S T O F T A B L E S  
Ta ble  1. 
List of varia bles a n d d efi niti o ns ............................................................... 2 2  
Ta ble  2. 
Precisi o n of t he esti mate ( 9 5 % CI) f or differe nt cli nical a n d 
micr o bi ol o gical s uccess rates a n d n u m ber of e val u a ble patie nts  ............. 2 7 
 
LI S T O F FI G U R E S  
Fi g ure 1 St u d y desi g n .............................................................................................................. 1 7  
 
  
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 7 of 5 7  
2.  LI S T O F A B B R E VI A TI O N S  
A b bre vi ati o n  
Ter m  
A -aD o 2 
al ve olar -arterial o x y ge n gra die nt  
A B G  
arterial bl o o d gas  
A E  
a d verse e ve nt 
A E M  
a d verse e ve nt m o nit ori n g  
AI D S  
Ac q uire d I m m u n o deficie nc y S y n dr o me 
A P A C H E  II 
 
Ac ute P h ysi ol o g y a n d C hr o nic Healt h E val uati o n  II 
A P S  
T otal Ac ute P h ysi ol o g y Sc ore  
C AI  
c o m m u nit y-ac q uire d i nfecti o n  
C A R S S  
C hi na A nti micr o bial Resista n ce S ur veilla nce S yste m  
C E  
cli nicall y e val ua ble 
C HI N E T  
C hi na A nti micr o bial S ur veilla nce Net w or k  
CI  
 
c o nfi de nce i nter val 
cI AI  
c o m plicate d i ntra -a b d o mi nal i nfecti o n  
C L SI  
Cli nical a n d La b orat or y Sta n dar ds I nstit ute  
C P  
car ba pe ne mase -pr o d uci n g  
C R E  
car ba pe ne m-resista nt E nter o b acteri ace ae  
C R F  
case re p ort f or m 
C R O  
c o ntract researc h or ga nizati o n  
C R P A  
car ba pe ne mase -pr o d uci n g Pse u d o m o n as aer u gi n os a  
C R K P  
car ba pe ne m-resista nt Kle bsiell a p ne u m o ni ae  
C S A  
cli nical st u d y a gree me nt  
C T  
c o m p ute d t o m o gra p h y  
D C T  
data c ollecti o n t o ol  
e C R F  
electr o nic case re p ort f or m 
E D P  
e x p os ure d uri n g pre g na nc y  
E M A  
E ur o pea n Me dici nes A ge nc y  
E N Ce P P  
E ur o pea n Net w or k of Ce ntres f or P har mac oe pi de mi ol o g y a n d 
P har mac o vi gila nce  
E O T  
e n d of treat me nt 
F A S  
f ull a nal ysis set 
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
Fi O 2 
fracti o n of i ns pire d o x y ge n 
G C S  
Glas g o w C o ma Scale  
H A  
h os pital -ac q uire d 
H AI  
h os pital -ac q uire d i nfecti o n  
H A P  
h os pital -ac q uire d p ne u m o nia 
H C AI  
healt hcare -ass ociate d i nfecti o n  
H C O 3 
bicar b o nate  
I AI 
i ntra-a b d o mi nal i nfecti o n  
I C U 
i nte nsi ve care u nit 
I E C 
I n de pe n de nt Et hics C o m mittee 
I R B 
I nstit uti o nal Re vie w B oar d 
I S P E 
I nter nati o nal S ociet y f or P har mac oe pi de mi ol o g y 
I S P O R 
I nter nati o nal S ociet y f or P har mac oec o n o mics a n d O utc o mes Researc h 
I V 
i ntra ve n o us 
K P C  
Kle bsiell a p ne u m o ni ae  car ba pe ne mase  
L O S  
le n gt h of sta y 
L T O  
Li mite d Treat me nt O pti o ns  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 8 of 5 7  
A b bre vi ati o n  
Ter m  
MI C  
mi ni m u m i n hi bit or y c o nce ntrati o n  
M D R  
m ulti -dr u g resista nt  
M D R -G N B  
M ulti dr u g -resista nt gra m-ne gati ve bacilli  
M E  
micr o bi ol o gicall y e val ua ble  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
m g  
milli gra m  
m m H g  
milli meter of merc ur y  
M RI  
ma g netic res o na nce i ma gi n g  
NI  
n o n -i nter ve nti o nal 
NI S  
n o n -i nter ve nti o nal st u d y 
N P  
n os oc o mial p ne u m o nia  
Pa O 2 
partial press ure of o x y ge n  
P V  
p har mac o vi gila nce  
S A E  
seri o us a d verse e ve nt 
S A P  
Statistical A nal ysis Pla n  
S O F A  
Se q ue ntial Or ga n Fail ure Assess me nt  
V A P  
ve ntilat or -ass ociate d p ne u m o nia  
W H O  
W orl d Healt h Or ga nizati o n  
X D R -G N B  
E xte nsi vel y dr u g -resista nt gra m-ne gati ve bacilli  
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 9 of 5 7  
3.  R E S P O N SI B L E P A R TI E S  
Pri nci p al I n vesti g at or(s) of t he Pr ot oc ol 
N a m e, de gree(s)  
J o b Title  
Affili ati o n  
A d dress  
Mi n g g ui Wa n g, M D  
Pr ofess or , C hief of 
I nstit ute of A nti bi otics 
H uas ha n H os pital 
F u da n U ni versit y  
N o. 1 2 W ul u m u qi Mi d dle R oa d 
Ji n ga n District, S ha n g hai, C hi na  
Wei y u n Z h u, P har m D  
Me dical A d vis or  
Pfizer  
T o wer B t he Mi n metals Plaza, 
N o. 3 7 N ort h C ha o ya n g me n 
A ve n ue D o n gc he n g District, 
Beiji n g, C hi na  
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 0  of 5 7  
4.  A B S T R A C T  
Title  
•  Real - W orl d St u d y of Ceftazi di me - Avi bact a m  t o C haract erize t he Usa g e i n Cli nical 
Practice   
•  Pr ot oc ol A me n d me nt 3, 1 2 A pril 2 0 2 2 
•  A ut h or:
, P har m D, 
Pfizer, C hi na;
 M D 
P h D,
 Pfizer, C hi na; 
, M Sc
Pfizer, C hi na;
 M D M Sc
Pfizer, N Y H Q . 
R ati o n ale a n d b ac k gr o u n d  
I nfecti o ns ca use d b y m ulti dr u g-resista nt gra m-n e g ati ve bacilli  (M D R -G N B) a n d e xte nsi vel y 
dr u g- resista nt gr a m-ne gati ve bacilli ( X D R -G N B) ca n be diffic ult t o treat  a n d are ass o ciate d 
wit h hi g h m or bi dit y , m ortalit y , a n d i ncreas e d  me dical b ur de n. T his c o nstit utes a seri o us 
t hreat t o p u blic healt h t hat t here is a n ur ge nt n ee d of ne w a nti bi otic a ge nts wit h acti vit y 
a gai nst M D R -G N B . C o nsi deri n g t he li mite d cases st u die d i n t he cli nical trials  a n d t he 
i ncreasi n g p ost-a p pr o val use of c eftazi di me-avi bacta m  i n cli nical setti n gs, it is necessar y t o 
u n dersta n d t he r eal- w orl d use of c eftazi di me-avi b acta m  f oc usi n g o n treat m e nt of X D R -G N B 
i nfecti o n, wit h  car b a pe n e m -resista nt Kle bsiell a p ne u m o ni ae  ( C R K P) as t he m ost fre q ue ntl y 
re p orte d p at h o ge n. 
Rese arc h Q uesti o n a n d O bjecti ves  
T he mai n o bjecti ve of t his o bser vati o nal st u d y is t o descri be t he real- w orl d usa ge, 
effecti ve ness a n d micr o bi ol o gical feat ures of c eftazi di me-avi bact a m  i n cli nical practice i n 
C hi na. 
St u d y desi g n  
T his o bser vati o nal st u d y will e nr oll a p pr o xi matel y 4 5 0 i n-patie nts  a m o n g a p pr o xi matel y 
2 0 cli nical researc h ce nters . Me dical i nf or mati o n  a n d micr o bi ol o gical outc o mes  fr o m 
h os pitalize d p atie nts treat e d wit h ≥1 d ose of c eftazi di me-avi bacta m  will be c ollecte d . T he 
recr uit me nt will last f or a p pr o xi matel y 6 m o nt hs or u ntil recr uit me nt tar get is met. Me dical  
i nf or mati o n will be c ollecte d fr o m t he p atie nts’ me dical rec or ds . Patie nts  will be f oll o we d 
fr o m t he first d ose of ceft azi di me-avi bacta m  u ntil deat h, wit h dra w of t he st u d y, 6 0 da ys 
f oll o wi n g h os pital disc har ge, w hic he v er c o mes first . The cli nical o utc o mes a n d 
micr o bi ol o gical o utc o mes will be e val uate d at : 7 d a ys, 1 4 da ys, 2 1 da ys, 3 0 da ys, 6 0 da ys, 
a n d e n d of tr eat me nt ( E O T)  after t he first d ose of ceftazi di me-avi bacta m , if patie nts are n ot 
disc har ge d pri or t o t he ne xt u pc o mi n g ti me p oi nt.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 1  of 5 7  
P o p ul ati o n 
H os pitalize d patie nts treate d wit h ≥1  d ose of ceftazi di m e-avi bact a m  at a p pr o xi matel y 2 0 
C hi na clinical researc h ce nters .  
V ari a bles   
•  E x p os ure: c eftazi di me- avi bacta m  
•  Ke y o utc o mes : cli nical o utc o mes , micr o bi ol o gical o utc o mes, le n gt h of h os pital sta y, 
rea d missi o n, deat hs a n d healt hcare res o urce utilizati o n  
•  Ke y c o variates: Patie nt d e m o gra p hics, i n dicati o ns, baseli ne c haracteristics, i nfecti o n 
s o urce ( h os pital/ c o m m u nit y) a n d hist or y of a nti bi otic(s) e x p os ure 
D at a s o urces  
T he st u d y data s o urce will be  me dical rec or d s fr o m t he partici pati n g cli nical researc h 
ce nters . T h e mic r o bi ol o g y is olates fr o m e nr olle d p atie nts, o btai ne d t hr o u g h r o uti ne 
pr oce d ur es (e g, ce ntrif u g ati o n  a n d p urificati o n) at t he l ocal la b  of partici pati n g cli nical 
researc h ce nters, will  be st or e d a n d tra ns p orte d t o a ce ntral la b, w he n a vaila ble, f oll o wi n g 
sta n dar d pr oce d ur e. At t he ce ntr al la b, t he pat h o ge n i de ntificati o n a n d t he s e nsiti vit y testi n g 
t o c o m m o n a nti bi otic dr u gs will be c o nfir me d. Ge n ot y pe c haracterizati o n  of 
car ba p e ne m -resista nt or g a nis ms will  be perf or me d . Ce ntral la b res ults will  be c ollecte d f or 
e pi de mi ol o g y p ur p ose o nl y a n d will n ot be se nt bac k t o partici pati n g cli nical researc h 
ce nters . Tra nsf er of micr o bi ol o g y is olates t o t he ce ntral la b will be d o ne f oll o wi n g l ocal la ws, 
re g ulati o ns a n d I nstit uti o nal Re vie w B oar d/ I n d e p e n de nt Et hics C o m mittee (I R B/I E C) 
rec o m me n dati o ns. 
St u d y size  
T he s t u d y will e nr oll a p pr o xi matel y 4 5 0 i n-patie nts treate d wit h ceftazi di m e-avi bacta m . 
D at a a n al ysis 
Patie nt de m o gra p hics, baseli ne c haracteristics , cli nical o utc o mes, micr o bi ol o gical o utc o mes, 
rea d missi o n rate, m ortalit y rate, hist or y of a nti o bi otic(s) treat me nt, a n d healt hcare res o urce 
utilizati o n  will be s u m marize d  f or h os pitalize d patie nts recei vi n g  ceftazi di me-avi bact a m  
treat me nt. Detaile d m et h o d ol o g y f or s u m mar y a n d statistical a nal yses of d ata c ollecte d i n 
t his st u d y will be d oc u me nte d i n a statistical a nal ysis pla n ( S A P). 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 2  of 5 7  
5.  A M E N D M E N T S A N D U P D A T E S  
A me n d me nt 
n u m ber  
D ate  
Pr ot oc ol secti o n(s) 
c h a n ge d  
S u m m ar y of a me n d me nt(s)  
Re as o n  
A me n d me nt 1  
Pr ot o c ol V 2. 0  
2 2 
Dece m ber 
2 0 2 1  
Researc h met h o ds ; 
Ma na ge me nt a n d re p orti n g 
of a d verse e ve nts ; 
A n ne x  
Mi n or c ha n ge i n St u d y desi g n;  
Defi niti o ns of varia bles;  
Data a bstracti o n sc he d ule; 
S pecif y Safet y re p orti n g 
re q uire me nt f or differe nt data 
s o urce 
1.  
T o descri be m ore detail o n 
st u d y desi g n a n d data 
a bstracti o n i nstr ucti o n. 
2.  
T o u p date t he safet y re p orti n g 
la n g ua ge t o ali g n wit h u p date d 
sta n dar d pr ocess. 
3.  
T o a d here t o Pfizer i nter nal 
versi o ni n g p olic y . 
 
A me n d me nt 2  
Pr ot o c ol V 3 . 0 
3 0 Ja n uar y 
2 0 2 2  
Milest o ne;  
Researc h met h o ds;  
A n ne x  
C ha n ge i n i ncl usi o n criteria; 
Defi niti o ns of setti n g;  
Recalc ulate st u d y size;  
Defi niti o ns of a nal ysis sets;  
Data a bstracti o n sc he d ule;  
1.  
T o i ncl u de patie nts wit h at 
least o ne d ose of C AZ- A VI  
2.  
T o u p date t he setti n g wit h 
m ore details . 
3.  
D ue t o t he c ha n ge of i ncl usi o n 
criteria, t he st u d y size was re-
esti mate d a n d t he title of data 
a bstracti o n sc he d ule was als o 
u p date d.  
4.  
T o clarif y t he a nal ysis sets  
b ase d o n u p date d p o p ulati o n .  
Pr ot o c ol 
A me n d me nt 3  
1 2 A pril 
2 0 2 2  
 
•  
St u d y title  
•  
Secti o n 7  
•  
Secti o n 8  
•  
Secti o n 9 a n d 9. 1. 1  
•  
Secti o n 9. 2  
•  
Secti o n 9. 3  
•  
Secti o n 9. 7. 2, 9. 7. 3  
•  
Secti o n 1 3  
•  
A n ne x   
•  
W h ole d oc u me nt: F or matti n g, gra m matical a n d mi n or e dit orial c ha n ges 
ha ve bee n ma de t hr o u g h o ut t he d oc u me nt. I n a d diti o n, c ha n ges ha ve 
bee n ma de t o secti o n hea di n g n u m bers , ta ble cr oss-refere nces, a n d 
refere nce listi n g w here necessar y, d ue t o a me n d me nts detaile d i n t his 
d oc u me nt.  
•  
Title : st u d y title has bee n re vise d t o better descri be t he p ur p ose of t he 
st u d y  
•  
Rati o nale a n d bac k gr o u n d: t he rati o nale a n d bac k gr o u n d secti o n has 
bee n strea mli ne d.  
•  
Researc h q uesti o n a n d o bjecti ves: t he descri pti o n of pri mar y a n d 
sec o n dar y o bjecti ves ha ve bee n refi ne d wit h n o maj or c ha n ges. 
Rec urr e nce d ue t o t he sa me i nfecti o n wit hi n 3 0 da ys after treat me nt 
c o m pleti o n has bee n re m o ve d fr o m t he sec o n dar y o bjecti ves 
c o nsi deri n g t he l ocal practice feasi bilit y. C orres p o n di n g e n d p oi nts a n d 
esti ma n ds ha ve bee n re vise d t o reflect t he c ha n ges ma de i n st u d y  
o bjecti ves a n d t o s pecif y t he e val uati o n ti me p oi nts.   
•  
St u d y desi g n: re m o ve ‘c ure d’ fr o m patie nt’s f oll o w -u p peri o d t o be 
c o nsiste nt wit h t he pri mar y o bjecti ve of t he st u d y. Descri pti o n of st u d y 
desi g n has bee n refi ne d wit h n o maj or c ha n ges.  
•  
Setti n g: t he setti n g secti o ns has bee n refi ne d a n d re place d t he ter m 
‘sites’ t o ‘cli nical researc h ce nters’.  
•  
Varia bles: data c ollecti o n o n Se q ue ntial Or ga n Fail ure Assess me nt 
( S O F A) has bee n a d de d a n d t he o perati o nal defi niti o n of Ac ute 
P h ysi ol o g y a n d C hr o nic Healt h E val uati o n  II ( A P A C H E II) ha s bee n 
re vise d acc or di n g t o l ocal cli nical practice feasi bilit y. A P A C H E II 
sc ore is m ore diffic ult t o o btai n at sta n dar d cli nical practice, t h us 
i ncl u de d t he c ollecti o n of  S O F A sc ore t o better e val uate disease 
se verit y of e nr olle d patie nts. 
•  
S o urce of i nfecti o n: defi niti o n of h os pital -ac q uire d i nfecti o n ( H AI) a n d 
c o m m u nit y -ac q uire d i nfecti o n ( C AI) ha ve bee n re vise d, a n d  t he 
descri pti o n of healt hcare -ass ociate d i nfecti o n ( H C AI) has bee n 
re m o ve d base d o n l ocal cli nical practice c o nsi derati o n.  
•  
A nal ysis of t he pri mar y a n d sec o n dar y e n d p oi nt: a nal ysis o n rec urre nce 
rate of i n de x i nfecti o n wit hi n 3 0 da ys after treat me nt c o m pleti o n  has 
bee n re m o ve d , a n d t he a nal ysis o n le n gt h of mec ha nical ve ntilati o n h as 
bee n a d de d  t o be c o nsiste nt wit h t he c ha n ges ma de i n st u d y o bjecti ves. 
Mi n or e dit orial c ha n ges ha ve  bee n ma de i n ot her descri pti o n of a nal ysis 
of t he pri mar y e n d p oi nt s wit h no maj or c ha n ges.    
•  
A n ne x 6: S O F A sc ore has bee n a d de d t o t he a n ne x t o reflect t he 
c ha n ges ma de i n varia ble  secti o n.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 3  of 5 7  
6.  MI L E S T O N E S  
Milest o ne  
Pl a n ne d d ate  
Start of data c ollecti o n  
0 1 J ul y 2 0 2 2  
E n d of data c ollecti o n   
2 8  Fe b r uar y 2 0 2 3 or later , if t he sa m ple 
size is n ot reac he d 
I nteri m re p ort 1 
o nce t he cli nical  o utc o me s at e n d of 
treat me nt ( E O T) are c ollecte d f or 2 0 0 
patie nts i n t he case re p ort f or m ( C R F)  
Fi nal st u d y re p ort  
3 0 Se pte m ber 2 0 2 3  
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 4  of 5 7  
7.  R A TI O N A L E A N D B A C K G R O U N D  
Wit h e xte nsi ve use of car ba pe ne ms, t he pre vale n ce of car ba p e ne m -resistant Kle bsiell a   
p ne u m o ni ae  ( C R K P strai ns are i ncreasi n g.  T he 2 0 1 4- 2 0 1 9 a nti micr o bial resista nce 
s ur veilla nce r e p ort iss ue d b y C hi na A nti micr o bial Resista nce S ur veilla nce S yste m ( C A R S S) 
p oi nte d o ut t hat t he detecti o n rate of C R K P  c o nti n ue d t o i ncreas e fr o m 6. 4 % i n 2 0 1 4 t o 
1 0. 9 % i n 2 0 1 9. 1 Acc or di n g t o C hi na A nti micr o bial S ur veilla nce N et w or k (C HI N E T ) 2 0 2 0 
data, t he resista n ce r ates of Kle bsiell a p ne u m o ni ae  t o i mi pe ne m a n d mer o p e ne m i ncrease d 
fr o m 3. 0 % a n d 2. 9 % i n 2 0 0 5 t o 2 3. 2 % a n d 2 4. 2 % i n 2 0 2 0, res pecti vel y.2 
I nfecti o ns ca use d b y m ulti dr u g-resista nt gra m-n e g ati ve bacilli ( M D R -G N B a n d e xte nsi vel y 
dr u g- resista nt gr a m-ne gati ve bacilli ( X D R -G N B  ca n be diffic ult t o treat a n d are ass o ciate d 
wit h hi g h m or bi dit y , m ortalit y , a n d i ncreas e d me dical b ur de n. T his c o nstit utes a seri o us 
t hreat t o p u blic healt h t hat t here is a n ur ge nt n ee d of ne w a nti bi otic a ge nts wit h acti vit y 
a gai nst M D R -G N B. Acc or di n g t o a retr os pecti ve a nal ysis a m o n g patie nts wit h i ntra -
a b d o mi nal i nfecti o ns (cI AI) i n C hi na, Esc heric hi a c oli  ( 3 4. 5 %) a n d Kle bsiell a p ne u m o ni ae 
( 2 1. 2 %) w ere t he l ea di n g pat h o ge ns i n patie nts wit h h os pital-ac q uire d ( H A) cI AI. M ost 
car ba p ene m -resista nt E nt er o b acteri ace a e  ( C R E) is olates carrie d blaK P C  ( 8 0. 9 %), f oll o we d b y 
bla N M D  ( 1 9. 1 %).3 St u dies i n C hi na de m o nstrate d a H A -cI AI rate of 3. 2 2 %- 5. 2 2 % a n d a 
h os pital-ac q uire d p n e u m o nia ( H A P) rate of 1. 7 6 % t o 1. 9 4 %. 4- 5 H A P has bee n ass oci ate d 
wit h  m ulti dr u g -resista nt gra m-ne g a ti ve bacterial i nfecti o n a m o n g patie nts i n i nte nsi ve care 
u nits or recei vi n g mec h a nical ve ntilati o n .6 I nade q uate e m piric a nti bi otic t h era p y has b ee n 
c o nsi dere d  b y s e ver al e pi de mi ol o gical st u dies as o ne of t he ris k fact ors of i n- h os pital deat h s, 
a n d t he fail ur e of i nitial e m piric a nti bi otic t hera p y was ass ociate d wit h hi g her m or bi dit y, 
m ortalit y, a n d  i ncreas e d me dical b ur de n.  7-1 1  
Car ba pe n e ms ha ve bee n use d as t he last res ort treat me nt f or gra m-ne gati ve bacteria ca usi n g 
i nfecti o ns. T he e v er i ncr easi n g n u m ber of i nfecti o ns ca use d b y C R E  a n d car ba pe ne m -
resista nt pse u d o m o nas aer u gi n osa ( C R P A) p ose d a maj or t hera pe utic c h alle n ge  t hat t here is 
a n ur ge nt nee d of n o vel a nti bi otics a ge nts wit h acti vit y a gai nst M D R -G N B . 1 2 -1 3 Za vicefta ® 
(ceft azi di me-a vi b acta m), w hic h i n hi bits t he acti vities of A m bler class es A a n d C β-lacta mase 
(i ncl u di n g t he Kle bsiell a p ne u m o ni ae  car ba p e ne m ase, K P C ), was a p pr o ve d i n C hi na o n 2 1 
Ma y 2 0 1 9 f or t he tr eat me nt of cI AI, H A P / ve ntilat or-ass ociat e d p ne u m o nia ( V A P), a n d 
i nfecti o ns wit h li mite d o pti o ns ca use d b y Kle bsiell a  p ne u m o ni ae , E nter o b a cter  cl o ac ae, 
Esc heric hi a c oli , Pr ote us mir a bilis  a n d Pse u d o m o n as aer u gi n os a  i n a d ult patie nts. 1 4 
Za viceft a ® is a u ni q ue c o m bi nati o n of ceftazi di me a n d t he n o ve l β -l acta m ase i n hi bit or 
a vi bacta m . Ceftazi di me e xerts its a nti bacterial effect b y bi n di n g t o pe nicilli n- bi n di n g 
pr otei ns, t here b y i n hi biti n g pe pti d o gl yca n cr ossli n ki n g d uri n g cell wall s y nt heses, lea di n g t o 
bacterial cell l ysis a n d deat h.  
Ceftazi di me -a vi b acta m  efficac y ha ve b ee n assesse d i n P hase II trials a n d i n n o n- i nferi orit y 
P hase III trials. C eftazi di me-a vi bact a m  pl us metr o ni daz ole was c o m pare d t o mer o pe ne m i n 
patie nts wit h cI AI, r es ults de m o nstrate d t hat ceftazi di me -a vi bact a m  was n o n -i nferi or f or 
cli nical c ure rate f or I AI; C eftazi di me-a vi b acta m  was c o m pare d t o mer o pe ne m i n patie nts 
wit h H A P  i ncl u di n g V A P, res ults s h o we d t hat ceftazi di me-a vi bacta m  was n o n -i nferi or f or 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 5  of 5 7  
cli nical c ure rate. 1 5 -1 8 Ceftazi di me-a vi bacta m  i n vitr o acti vit y a gai nst C R E has bee n s h o w n. 
Pre vi o us st u dies ha ve re p orte d t hat ceftazi di me-a vi bacta m has  hi g her cli nical s uccess i n 
C R K P  i nfecti o ns, i ncl u di n g uri nar y tract i nfecti o ns,  p ne u m o nia, a n d bl o o dstrea m i nfecti o ns. 
H o we ver, t here is li mite d e vi de nce of ceftazi di me-a vi bacta m  i n efficac y i n ce ntral ner v o us 
s yste m i nfecti o ns t hat fut ure st u dies are nee d e d . 1 9 -2 5  Res ults fr o m 7 P hase II a n d P hase III 
cli nical trials  a m o n g 2 0 2 4 a d ult patie nts treate d wit h ceftazi di me-a vi bacta m s h o we d t hat  
m ost c o m m o n a d verse r eacti o ns occ urri n g i n ≥5 % of patie nts were p ositi ve C o o m bs direct 
tests, na usea, a n d diarr hea. Na usea a n d diarr hea w ere us uall y mil d or m o derate i n i nte nsit y.1 4 
C o nsi deri n g t he li mite d cases st u die d i n cli nical tri als a n d t he i ncreasi n g p ost -a p pr o val use of 
ceftazi di me-a vi bacta m i n cli nical setti n g s, it is necessar y t o u n dersta n d t he real- w orl d  use 
patter n  a n d effecti ve n ess  of  ceftazi di me-a vi bact a m i n cli nical practice. T his st u d y f urt her 
c ollects t he  is olates fr o m  e nr olle d  patients  t o u n dersta n d  t he   distri b uti o n, a nti micr o bial 
s usce pti bility  patter n,  a n d ge n ot y pe  c hara cteristics  of  car b a pe ne m -resista nt  or ga nis ms. 
Fi n di n gs fr o m t his st u d y ca n pr o vi d e t he b asis o n ceftazi di me-a vi bacta m treat me nt of X D R-
G N B i nfecti o n , i ncl u di n g C R E, i n cli nical practice.  
8.  R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S  
T he mai n o bjecti ve of t his o bser vati o nal st u d y is t o descri be t he real- w orl d usa ge, 
effecti ve ness a n d micr o bi ol o gical feat ures of ceftazi di me-a vi bact a m  i n cli nical practice i n 
C hi na. 
T he pri mar y o bjecti ves of t his st u d y are t o: 
•  Descri be t h e cli nical o utc o mes of patie nts (i .e., treat me nt s uccess, fail ure, or 
i n deter mi nate) at Da y 7 ( ±  3 da ys), Da y  1 4 (±  3 d a ys ), Da y  2 1 (±  3 da ys), Da y  3 0 (±  
3 da ys), Da y  6 0 (±  3 da ys ), a n d at e n d of treat me nt (E O T)  (±  3 da ys) after 
ceftazi di me-a vi bacta m  tr eat me nt i nitiati o n, if patie nts are n ot disc har ge d pri or t o t he 
ne xt u pc o mi n g ti me p oi nt. 
•  Descri be t h e micr o bi ol o gic al o utc o mes of patie nts  at Da y 7 ( ±  3 da ys), Da y 1 4 (±  3 
da ys), Da y 2 1 ( ±  3 da ys), Da y 3 0 (±  3 da ys), D a y 6 0 (±  3 da ys), a n d at E O T (±  3 
da ys) after ceftazi di me-a vi bacta m  treat me nt i nitiati o n, if patie nts are n ot disc har ge d 
pri or t o t he ne xt u pc o mi n g ti me p oi nt. 
•  Descri be t he real-w orl d us a geof ceftazi di me-a vi b acta m  at cli nical practice, i ncl u di n g 
patie nt baseli ne c h aracteristics, t y pe of i nfecti o n, s o urce of i nfecti o n, etc. 
•  Descri be t he micr o bi ol o gical feat ures  of is olate d strai ns at baseli ne, i ncl u di n g pat h o ge n 
i de ntificati o n, distri b uti o n, s usce pti bilit y  of ceftazi di me-a vi bacta m  a n d ot her c o m m o n 
a nti bi otic
 dr u gs
 i ncl u di n g
 car ba p e ne m -resista nt
 or ga nis ms,
 a n d
 ge n ot y pe
 
c haracteristics of car b a pe ne m -resista nt or g a nis ms. 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 6  of 5 7  
T he s ec o n d ar y o bjecti ves of t his st u d y are t o:  
•  Descri be t h e a nti bi otic treat me nt a d mi nist ered t o t he e nr olle d patie nts, i ncl u di n g t he 
d osa ge, fr e q ue nc y, d urati o n (start a n d e n d d ates) of ceft azi di me-a vi b acta m , a n d 
c o m bi nati o n me dicati o ns wit h ceftazi di me -a vi bact a m .  
•  Descri be t h e i n - h os pital le n gt h of sta y ( L O S), L O S i n I C U a n d healt hcare res o urce 
utilizati o n  i n patie nts treate d wit h ceftazi di me-a vi b acta m . 
•  Descri be t h e rea d missi o n rate d ue t o t he rec urre n ce of i nfecti o n  ha p pe ne d i n t he sa me 
l ocati o n 3 0 a n d 6 0 da ys after disc har ge.   
•  Deter mi ne t he i n - h os pital all-ca use m ort alit y.   
 
9.  R E S E A R C H M E T H O D S  
9. 1.  St u d y d esi g n   
T his is a m ultice nter,  o bser vati o nal st u d y ai mi n g t o e xa mi ne t he real-w orl d usa ge, 
effecti ve ness a n d micr o bi ol o gical feat ures of c eftazi di me-avi bact a m  i n cli nical practice  at 
a p pr o xi matel y 2 0 cli nical researc h ce nters  i n C hi n a. A p pr o xi matel y 4 5 0 h os pitalize d patie nts  
recei vi n g ≥1 d ose of  ceftazi di me-avi bacta m  fr o m 0 1 J ul y 2 0 2 2 t o 3 1 Dece m ber 2 0 2 2 will be 
e nr olle d. T he r ecr uit me nt will last f or a p pr o xi matel y 6 m o nt hs or u ntil recr uit me nt tar get is 
met . Eli gi ble patie nts are a d ult patie nts w h o ha ve bee n treate d wit h ≥1 d ose of c eftazi di me-
avi bacta m  d uri n g h os pitalizati o n . Eac h patie nt will be o nl y i ncl u de d i n t he st u d y o nce. 
Me dical i nf or mati o n will be c ollecte d fr o m t he patie nts’ me dical rec or ds . P atie nts will be 
f oll o we d fr o m t he first d ose of ceftazi di me-avi bacta m  u ntil deat h, wit h dra w of t he st u d y, 6 0 
da ys f oll o wi n g h os pital disc har ge, w hi c he ver c o m es first . The cli nical o utc o mes a n d 
micr o bi ol o gical o utc o mes will be e val uate d at : 7 d a ys, 1 4 da ys, 2 1 da ys, 3 0 da ys, 6 0 da ys, 
a n d E O T aft er t he first d ose of ceftazi di me-avi bacta m , if patie nts are n ot disc har ge d pri or t o 
t he ne xt u pc o mi n g ti me p oi nt. T he cli nical a n d micr o bi ol o gical o utc o mes will be assesse d b y 
t he i n vesti gat or a n d rec or de d i n case re p ort f or m  (C R F ).  
T he st u d y data c ollecti o n a n d assess me nt sc h e d ule are des cri be d i n  Fi g ure 1 . All assess me nts 
descri be d i n t his n o n-i nter ve nti o nal pr ot oc ol are p art of C hi na cli nical practice or treat me nt 
g ui deli nes.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  2 0 -Ma y -2 0 2 1  
Pa ge 1 7  of 5 7  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fi g ure 1 St u d y d esi g n
 
D ate of 
a d missi o n or 
7 d a ys bef ore 
i n de x d ate 
I n de x d ate 
 ( Recei ve ≥1 d ose 
of ceft azi di me -
a vi b act a m)  
Recei ve at le ast 
7 2 h o urs of 
ceft azi di m e -
a vi b act a m  
D a y 7, D a y 1 4, D a y 2 1, D a y 3 0, D a y 
6 0, a n d at E O T after i n de x d ate *  
E n d of 
o bser v ati o n  
Ce ntr al l a b 
e v al u ati o n 
Cli n ic al O utc o m es a n d Micr o bi ol o gic al 
O utc o m es Assess m e nt  
B aseli ne Peri o d  
Fr o m date of a d missi o n t o i n de x date or 
fr o m 7 da ys bef ore i n de x date t o i n de x 
date, w hic he ver is l o n ger  
* O utc o mes will be e val uate d at eac h ti me p oi nt if patie nts are n ot disc har ge d pri or t o t he ne xt u pc o mi n g ti me p oi nt. T hree da y s i de ntificati o n 
wi n d o w  will be a p plie d bef ore a n d after eac h ti me p oi nts.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 8  of 5 7  
9. 1. 1.  E n d p oi nts a n d esti m a n ds  
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
Pri m ar y:  
Pri m ar y:  
Pri m ar y:  
Descri be t he cli nical 
o utc o mes of patie nts (i.e., 
treat me nt s uccess, fail ure, or 
i n deter mi nate) at Da y 7 ( ± 3 
da ys), Da y 1 4 ( ± 3 da ys), 
Da y 2 1( ± 3 da ys), Da y 3 0 ( ± 
3 da ys), Da y 6 0 ( ± 3 da ys), 
a n d at E O T ( ± 3 da ys) after 
ceftazi di me -a vi bacta m  
treat me nt i nitiati o n, if 
patie nt s are n ot disc har ge d 
pri or t o t he ne xt u pc o mi n g 
ti me p oi nt. 
•  
Cli nical o utc o me  
•  
T he cli nical s uccess rate at Da y 7 ( ± 3 
da ys), Da y 1 4 ( ± 3 da ys), Da y 2 1  ( ± 3 
da ys), Da y 3 0 ( ± 3 da ys), Da y 6 0 ( ± 3 
da ys), a n d at E O T  ( ± 3 da ys) after 
ceftazi di me -a vi bacta m  treat me nt 
i nitiati o n, if patie nts are n ot disc har ge d 
pri or t o t he ne xt u pc o mi n g ti me p oi nt.  
Descri be t he micr o bi ol o gic al 
o utc o mes of patie nts at Da y 
7 ( ± 3 da ys), Da y 1 4 ( ± 3 
da ys), Da y 2 1 ( ± 3 da ys), 
Da y 3 0 ( ± 3 da ys), Da y 6 0 ( ± 
3 da ys), a n d at E O T ( ± 3 
da ys) after ceftazi di me -
a vi bacta m  treat me nt 
i nitiati o n, if patie nts are n ot 
disc har ge d pri or t o t he ne xt 
u pc o mi n g ti me p oi nt.  
•  
Micr o bi ol o gical 
o utc o me  
•  
T he micr o bi ol o gical s uccess rate at Da y 7 
( ± 3 da ys), Da y 1 4 ( ± 3 da ys), Da y 2 1( ± 3 
da ys), Da y 3 0 ( ± 3 da ys), Da y 6 0 ( ± 3 
da ys), a n d at E O T  ( ± 3 da ys) after 
ceftazi di me -a vi bacta m  i nitiati o n, if 
patie nts are n ot disc har ge d pri or t o t he 
ne xt u pc o mi n g ti me p oi nt . 
 
Descri be t he real -w orl d 
usa ge  of ceftazi di me-
a vi bacta m at cli nical 
practice, i ncl u di n g patie nt 
baseli ne c haracteristics, t y pe 
of i nfecti o n, s o urce of 
i nfecti o n, etc. 
•  
 
•  
Baseli ne c haracteristics  
•  
I n dicati o n 
•  
S o urce of i nfecti o n  
•  
T he  n u m ber a n d  perce nta ge of  patie nts b y 
de m o gra p hic c haracteristics, i n dicati o n, 
ty pe a n d s o urce of i nfecti o n .   
 
Descri be t he micr o bi ol o gical 
feat ures of is olate d strai ns, 
i ncl u di n g pat h o ge n 
i de ntificati o n, distri b uti o n, 
s usce pti bilit y of ceftazi di me-
a vi bacta m a n d ot her 
c o m m o n a nti bi otic dr u gs 
i ncl u di n g car ba pe ne m-
resista nt or ga nis ms, a n d 
ge n ot y pe c haracteristics of 
car ba pe ne m-resista nt 
or ga nis ms.  
At baseli ne:  
•  
Pat h o ge n i de ntificati o n  
•  
Dr u g s usc e pti bilit y  
•  
Ge n ot y pe a n d  t y pe of 
e nz y me   
•  
T he n u m ber a n d perce nta ge of is olate d 
strai ns.  
•  
S usce pti bilit y a n d resista nce rate of 
ceftazi di me -a vi bacta m a n d ot her c o m m o n 
a nti bi otic dr u gs 
•  
T he n u m ber a n d perce nta ge of 
car ba pe ne m-resista nt or ga nis ms 
Sec o n d ar y:  
Sec o n d ar y:  
Sec o n d ar y:  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 1 9  of 5 7  
Descri be t he a nti bi otic 
treat me nt a d mi nistrate d t o 
t he e nr olle d patie nts, 
i ncl u di n g t he d osa ge , 
fre q ue nc y, d urati o n of 
ceftazi di me -a vi bacta m , a n d 
co m bi nati o n  me dicati o ns 
wit h ceftazi di me -a vi bacta m 
•  
D ose  
•  
Fre q ue nc y  
•  
D urati o n of e x p ose  
(start a n d e n d dates) 
•  
C o m bi nati o n t hera p y  
•  
T he n u m ber a n d perce nta ge of patie nts 
treate d i n differe nt d ose a n d fre q ue nc y of 
ceftazi di me -a vi bacta m . 
•  
T he descri pti ve statistics  o n t he d urati o n 
of e x p os ur e t o ceftazi di me -a vi bacta m . 
•  
T he n u m ber a n d perce nta ge of patie nts 
recei vi n g c o m bi nati o n t hera p y wit h 
ceftazi di me -a vi bacta m . 
•  
T he n u m ber a n d perce nta ge of patie nts i n 
eac h c o m bi nati o n t hera p y wit h 
ceftazi di me -a vi bacta m . 
Descri be t he i n -h os pital 
L O S, L O S i n I C U a n d 
healt hcare res o urce 
utilizati o n i n patie nts treate d 
wit h ceftazi di me -a vi bacta m. 
•  
L O S  
•  
L O S i n I C U  
•  
A d missi o n dia g n osis  
•  
Disc har ge dia g n osis  
•  
C o nc o mita nt  
pr oce d ure s  
•  
Mec ha nical ve ntilati o n  
•  
Descri pti ve statistics of L O S a n d I C U 
L O S.  
•  
T he n u m ber a n d perce nta ge of patie nts b y  
differe nt a d missi o n a n d  disc har ge 
dia g n osis.  
•  
T he n u m ber a n d perce nta ge of patie nts 
wit h  i n vasi ve pr oce d ures , s o urce of 
i nfecti o n ma na ge me nt, dial ysis, s ur ger y, 
etc 
•  
Le n gt h of mec ha nical ve ntilati o n  
Descri be  t he rea d missi o n 
rate d ue t o t he rec urre nce of 
i nfecti o n ha p pe ne d i n t he 
sa me l ocati o n  3 0 a n d 6 0 
da ys after disc har ge.  
 
•  
Rea d missi o n  
 
•  
T he perce nta ge  of patie nts wit h a n y 
rea d missi o n d ue t o rec urre nce of 
i nfecti o n ha p pe ne d i n t he sa me l ocati o n 
wit hi n 3 0 a n d 6 0 da ys after disc har ge.  
 
Deter mi ne t he i n -h os pital 
all-ca use m ortalit y. 
•  
Deat h  
•  
T he perce nta ge  of patie nts treate d b y 
ceftazi di me -a vi bacta m  die d d uri n g 
h os pitalizati o n.  
 
9. 2.  Setti n g  
Patie nts will be e nr olle d fr o m a p pr o xi matel y 2 0 cli nical researc h ce nters  i n C hi na. Cli nical 
researc h ce nters will be e val uate d a n d t he n s electe d base d o n t he ca pa bilit y of c o n d ucti n g t he 
st u d y. 
I n v esti gat ors will start eli gi bilit y scree ni n g a n d recr uit me nt fr o m a d ult patie nts w h o recei v e d  
ceftazi di me-a vi bacta m  tr eat me nt. Patie nts w h o pr o vi de writte n i nf or me d c o nse nt a n d w h o 
f ulfill t he eli gi bilit y criteria will be e nr olle d i n t he st u d y. Eli gi bilit y criteria f or patie nt 
e nr oll me nt i n t he st u d y ha ve bee n s u m marize d i n Secti o n 9. 2. 1  a n d Secti o n 9. 2. 2 . Patie nts 
partici pati n g i n  cli nical trials are e x cl u de d fr o m t his st u d y beca use pr ot o c ol -dri ve n acti vities 
ma y be o utsi de of n or mal practice a n d c o ul d c o nf o u n d effecti ve ness ass ess me nts.  Eac h 
patie nt will be o nl y i ncl u de d i n t he st u d y o nce. 
T he i n de x h os pitalizati o n will be  defi ne d as p atie nts ’ first h os pitalizati o n met t he eli gi ble 
criteria.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 0  of 5 7  
T he i n de x date will be d efi ne d as t he dat e of patie nts i nitiate d ≥1 d ose of ceftazi di me-
a vi bacta m  treat me nt d uri n g t he i n de x h os pitalizati o n. 
T he e nr oll me nt peri o d is fr o m 0 1 J ul y 2 0 2 2 t o 3 1 Dece m b er 2 0 2 2 or lat er if t he sa m ple size 
is n ot reac he d. Patie nts w h o i nitiate d treat me nt wit h ≥1  d ose of ceftazi di me-a vi bacta m  d uri n g 
e nr oll me nt peri o d wil l be e nr olle d. 
T he data c ollecti o n peri o d is fr o m 0 1 J ul y 2 0 2 2 t o 2 8 Fe br u ar y  2 0 2 3 or l ater if t he sa m ple 
size is n ot reac h e d, patie nt’s  i nf or mati o n will be fille d i n C R F  d uri n g data c ollecti o n peri o d. 
T he  baseli ne p eri o d will be defi ne d as fr o m dat e of a d missi o n t o i n de x date or fr o m 7 da ys 
bef ore i n d e x date t o i n de x date, w hic h e v er is l o n g er. W he n  p atie nts ha ve m ulti ple rec or ds f or 
varia bles of i nterest d uri n g t he baseli ne peri o d, t he o ne cl osest t o t he i n de x date will be  
selecte d.   
9. 2. 1.  I ncl usi o n criteri a 
Patie nts  m ust meet all of t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or i ncl usi o n i n t he 
st u d y: 
1.  Initiate  ≥1 d ose of ceftazi di me-a vi bacta m  d uri n g h os pitalizati o n.  
2.  A ge d ≥ 1 8 years ol d at t he ti me of t he i nf or me d c o nse nt si g nat ure.  
3.  Pr o vi de si g n e d i nf or me d c o nse nt. 
9. 2. 2.  E xcl usi o n c riteri a 
Patie nt s meeti n g  a n y of t he f oll o wi n g criteria will n ot be i ncl u de d i n t he st u d y: 
1.  Are  e nr olle d i n a n y cli nical trial, i ncl u di n g e nr oll me nt i n n o n-i nter ve nti o nal st u dies. 
2.  Pre g na nt w o me n. 
9. 2. 3.  St u d y p o p ul ati o n 
H os pitalize d patie nts treate d wit h ≥1 d ose of ceftazi di me-a vi bact a m  at a p pr o xi matel y 2 0 
C hi na cli nical researc h ce nters .  
9. 2. 4.  Me dic al  i nf or m ati o n c ollecti o n  
Patie nt me dical i nf or mati o n will be c ollecte d as rec or de d i n patie nt’s me di cal rec or d  (e. g., 
patie nt i nf or mati o n, baseli ne c haracteristics  [disease c haracteristics a n d ris k fact ors], 
i nfecti o n status a n d e x p os ure varia bl e s).  
9. 2. 5.  B aseli ne  assess m e nt  
T he baseli ne assess me nt of t his st u d y is t he last assess me nt bef ore t he start of ceft azi di me-
a vi bacta m  treat me nt. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 1  of 5 7  
9. 2. 6.  Me di c al rec or d re vie w  
I n v esti gat ors will rec or d t he st u d y data i n C R F base d o n t he me dical rec or d  of t he e nr olle d 
patie nt . T he i n vesti gat ors will assess t he cli nical o utc o me a n d micr o bi ol o gical o utc o me a n d 
rec or d o n C R F. 
9. 2. 7.  Ce ntr al l a b assess m e nt 
T he micr o bi ol o g y is olates fr o m e nr olle d patie nts, o btai ne d t hr o u g h r o uti ne pr oce d ures (e. g., 
ce ntrif u gati o n a n d p urificati o n) at t he l ocal la b  of partici pati n g cli nical res earc h ce nters, will  
be st ore d a n d tr a ns p orte d t o a ce ntral la b, w he n a v aila ble, f oll o wi n g sta n dar d pr oce d ure. At 
t he ce ntral la b, t h e pat h o ge n i de ntificati o n a n d t he s usce pti bilit y testi n g t o c o m m o n a nti bi otic 
dr u gs will be c o nfir me d . Ge n ot y pe c h aracterizati o n  of c ar b a pe n e m -resista nt or ga nis ms  will  
be perf or me d . Ce ntral la b res ults will  be c ollecte d f or e pi de mi ol o g y p ur p os e o nl y a n d will 
n ot be se nt bac k t o partici pati n g cli nical researc h ce nters. Tra nsfer of micr o bi ol o g y is olates 
t o t he ce ntral la b will be d o ne f oll o wi n g l ocal la ws, re g ulati o ns a n d I nstit uti o nal Re vie w 
B oar d/ I n de pe n d e nt Et hics C o m mittee (I R B/I E C)  rec o m me n dati o ns.  
•  Strai n i de ntificati o n  
T he ce ntr al la b will use mass s pectr o metr y or ot h er met h o ds t o re- i d e ntif y C R E a n d CR P A 
strai ns. 
•  Dr u g s usce pti bilit y test 
Acc or di n g t o t he latest v ersi o n of t he Cli nical a n d La b orat or y Sta n dar ds I nstit ute ( C L SI ) 
d oc u me nt, t he ce ntr al la b uses t he br ot h micr o- dil uti o n met h o d t o deter mi ne t he mi ni m u m 
i n hi bit or y c o nce ntrati o n ( MI C) of t he C R E a n d C R P A strai n a gai nst cli nicall y c o m m o nl y 
use d a nti bacterial dr u gs, i ncl u di n g at least t he f oll o wi n g dr u gs : a mikaci n, cefta zi di me, 
mer o pe ne m, c olisti n, ti gec ycli ne, c eftazi di me-a vi b acta m  a n d ci pr ofl o xaci n  etc. 
•  Strai n  ge ne a n d c ar b a pe n e mase test  
T he ce ntr al la b will use m olec ular bi ol o g y met h o d t o detect car ba pe n e mas e ge nes (i n cl u di n g 
bla K P C , blaN D M , blaI P M, blaVI M  a n d blaO X A -4 8, etc).  
T he data ge n er ate d b y t h ose testi n g will be i ncl u de d i n t he fi nal a nal ys es re p ort f or t he st u d y. 
9. 2. 8.  D at a c ollecti o n  date  
T his st u d y will c ollect at least 2 8 0 patie nts wit h cli nical o utc o me a n d 2 2 0 p atie nts wit h 
micr o bi ol o gical o utc o me f or t he calc ulati o n of cli nical s uccess rate a n d micr o bi ol o gical 
s uccess r ate. T he s a m ple size calc ul ati o n is detaile d i n Secti o n 9. 4 . 
If t here ar e n ot e n o u g h n u m ber of patie nts wit h cli nical a n d micr o bi ol o gical o utc o me 
c ollecte d bef ore t he pl an ne d data c oll ecti o n e n d d ate, t he data c ollecti o n e n d data will be 
p ost p o ne d t o e nr oll m ore patie nts. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 2  of 5 7  
If t he re q uire d n u m ber of patie nts wit h cli nical a n d m icr o bi ol o gical o utc o me ca n be c ollecte d 
bef ore  t h e pla n ne d d ata c ollecti o n e n d date, t he e n d date will be m o ve d f or war d. If t he t otal 
n u m ber of patie nts d oe s n ot reac h 45 0, t he e n d date will be set t o a date w h e n at least 45 0 
patie nts ca n be e nr olle d.  
9. 3.  V ari a bles  
Ta ble 1  s h o ws t he list of e x p os ures, o utc o mes, a n d ot her varia bl es t o be c ollecte d i ncl u di n g 
ris k fact ors, c o m or bi dities, c o m bi nati o n me dicati o ns a n d c o nc o mita nt pr oce d ures. T he d etails 
o n data  a bstracti o n sc he d ule are pr o vi de d i n A N N E X 8 . 
T a ble 1. 
List of v ari a bles a n d d efi niti o ns  
V a ri a ble 
R ole  
O per ati o n al d efi niti o n 
I nf or me d c o nse nt 
Re q uire d f or 
p artici pati o n 
Si g ne d i nf or me d c o nse nt f or m s u b mitte d t o st u d y 
pers o n nel.  
A ge  
Baseli ne c haracteristic  
As rec or de d i n me dical rec or d. A ge at I C F si g n -
off . 
Se x  
Baseli ne c haracteristic  
As rec or de d i n me dical rec or d. 
War d  of a d missi o n  
Baseli ne c haracteristic  
As rec or de d i n me dical rec or d  
E m pl o y me nt  
Baseli ne c haracteristic  
As rec or de d i n me dical rec or d. 
Hei g ht, wei g ht  
Baseli ne c haracteristic  
Hei g ht a n d wei g ht as rec or de d i n me dical rec or d. 
Alc o h ol c o ns u m pti o n  
Baseli ne c haracteristic  
A lc o h ol c o ns u m pti o n as rec or de d i n me dical 
rec or d. 
S m o ki n g  
Baseli ne c haracteristic  
S m o ki n g fre q ue nc y as rec or de d i n me dical 
rec or d. 
C o m or bi dit y   
Baseli ne c haracteristic  
Assesse d t he baseli ne b y i n vesti gat or. See  
Secti o n 9. 3. 1 . 
Rece nt h os pitalizati o n  
Baseli ne c haracteristic  
Wit hi n 9 0 da ys pri or t o date of a d missi o n f or t he 
c urre nt h os pitalizati o n, date of a d missi o n  a n d 
disc har ge, reas o n f or h os pitalizati o n.  
Hist or y of a nti bi otic 
e x p os ure 
Baseli ne c haracteristic  
A nti bi otic(s) use d wit hi n 9 0 da ys pri or t o date of 
a d missi o n f or t he c urre nt h os pitalizati o n . 
Rece nt healt hcare 
pr oce d ure  
Baseli ne c haracteristic  
Wit hi n t he 3 0 da ys bef ore ceftazi di me -a vi bacta m  
i nitiati o n. 
Pre -treat me nt disease 
se verit y ( A P A C H E II, 
S O F A,  Pitt Bactere mia 
Sc ore , or  ot her 
pr o g n ostic  assess me nt)  
Baseli ne c haracteristic  
M eas ure d at ti me of recei vi n g 1 st d ose of 
ceftazi di me -a vi bacta m  treat me nt. F or I C U 
patie nts , rec or d t he A P A C H E II a n d S OF A 
sc ore; f or patie nts a d mitte d t o ot her war ds , 
A P C H E II a n d S O F A are rec or de d as a vaila ble.   
See Secti o n 9. 3. 2  f or A P A C H E II a n d S O F A 
sc ore. See Secti o n 9. 3. 3  f or Pitt Bactere mia 
Sc ore . See A N N E X 6  f or S O F A sc ore. 
A d missi o n dia g n osis  
Baseli ne c haracteristic  
Dia g n osis at t he start of t he h os pitalizati o n as 
rec or de d i n me dical rec or d. 
S o urce of i nfecti o n  
Baseli ne c haracteristic  / 
s u b-gr o u p i de ntifier  
As rec or de d i n me dical rec or d. See Secti o n 9. 3. 4 . 
In dicati o n f or 
ceftazi di me -a vi bacta m 
Baseli ne c haracteristic  / 
s u b-gr o u p i de ntifier  
S ite of i nfecti o n ( or ga n) a n d t y pe of i nfecti o n ; 
date of dia g n osis. See Secti o n 9. 3. 5 . 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 3  of 5 7  
T a ble 1. 
List of v ari a bles a n d d efi niti o ns  
V a ri a ble 
R ole  
O per ati o n al d efi niti o n 
Pre -treat me nt 
micr o bi ol o g y sa m ple  
Baseli ne c haracteristic  
Micr o bi ol o gical c ult ure(s) of c urre nt i nfecti o n 
bef ore ceftazi di me -a vi bacta m i nitiati o n (sa m ple 
date(s), sa m ple site(s)). 
Pre -treat me nt 
micr o bi ol o g y res ults  
Baseli ne c haracteristic  / 
s u b-gr o u p i de ntifier  
Res ults fr o m micr o bi ol o gical c ult ure ( met h o d of 
testi n g, i de ntifie d pat h o ge n(s), s usce pti bilit y, 
M D R)  bef ore ceftazi di me -a vi bacta m  i nitiati o n. 
See Secti o n 9. 3. 6 . 
Pri or a nti bi otic t hera p y  
Baseli ne c haracteristic  
A nti bi otic(s) use d f or c urre nt i nfecti o n bef ore 
ceftazi di me -a vi bacta m  i nitiati o n. Dates of 
a d mi nistrati o n, d ose(s), fre q ue nc y, d urati o n, 
r o ute of a d mi nistrati o n, reas o n of treat me nt 
disc o nti n uati o n, em piric or defi niti ve t hera p y  
( See Secti o n 9. 3. 7 ). 
C eftazi di me -a vi bacta m 
E x p os ure  
Dates of a d mi nistrati o n, d ose(s), fre q ue nc y, 
d urati o n, reas o n of treat me nt disc o nti n uati o n, 
em piric or defi niti ve t hera p y  ( See Secti o n 9. 3. 7 ). 
C o m bi nati o n  a nti bi otic 
t hera p y 
E x p os ure  /s u b-gr o u p 
i de ntifier 
Na me(s) of a nti bi otic(s) use d c o nc urre ntl y wit h 
ceftazi di me -a vi bacta m , dates of a d mi nistrati o n, 
d ose(s), fre q ue nc y, d urati o n, r o ute of 
a d mi nistrati o n, em piric or defi niti ve t hera p y  ( See 
Secti o n 9. 3. 7 ). 
Micr o bi ol o g y sa m ple 
after treat me nt i nitiati o n  
O utc o me  
Micr o bi ol o gical c ult ure(s) after ceftazi di me -
a vi bacta m  i nitiati o n (sa m ple date, sa m ple site). 
Micr o bi ol o g y res ults 
after treat me nt i nitiati o n  
O utc o me  
Res ults fr o m micr o bi ol o gical c ult ure after 
treat me nt i nitiati o n ( met h o d of testi n g, i de ntifie d 
pat h o ge n(s), s usce pti bilit y, M D R).  
Disc har ge dia g n osis  
O utc o me  
Dia g n osis w he n disc har ge.  
Cli nical o utc o me  
O utc o me  
S uccess, fail ure, a n d i n deter mi nate. See Secti o n 
9. 3. 8 . 
Micr o bi ol o gic al o utc o me  
O utc o me  
S uccess, fail ure, e mer ge nt i nfecti o ns a n d 
u ne val ua ble.  See  Secti o n 9. 3. 8 . 
Deat h (all -ca use 
m ortalit y) d uri n g 
h os pitalizati o n  
O utc o me  
Deat h d uri n g h os pitalizati o n after start of 
ceftazi di me -a vi bacta m  treat me nt. Date a n d 
all-ca use dea t h will be c ollecte d. 
Le n gt h of h os pital sta y 
O utc o me  
Date(s)  of  h os pital  a d missi o n, date(s)  of  h os pital  
disc har ge.  
A d missi o n date  
O utc o me  
As rec or de d i n me dical rec or d.  
Disc har ge date  
O utc o me  
As rec or de d i n me dical rec or d . 
Le n gt h of I C U sta y  
O utc o me  
Date(s)  of  I C U a d missi o n,  date(s)  of  I C U 
disc har ge.  
I C U a d missi o n date 
O utc o me  
As rec or de d i n me dical rec or d.  
I C U disc har ge date 
O utc o me  
As rec or de d i n me dical rec or d . 
H os pital rea d missi o n  
O utc o me  
H os pital rea d missi o n f or t he rec urre nce of 
i nfecti o n ha p pe ne d i n t he sa me l ocati o n 3 0 a n d 
6 0 da ys after disc har ge ; reas o n f or rea d missi o n, 
date of rea d missi o n.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 4  of 5 7  
T a ble 1. 
List of v ari a bles a n d d efi niti o ns  
V a ri a ble 
R ole  
O per ati o n al d efi niti o n 
Healt hcare res o urce 
utilizati o n  
O utc o me  
Detaile d list of t hera pe utic a n d dia g n ostic 
pr oce d ures  ( mec ha nical ve ntilati o n, dial ysis, 
c o m p ute d t o m o gra p h y  [C T ], ma g netic res o na nce 
i ma gi n g [M RI ], i n vasi ve pr oce d ures, ot her) a n d 
dates of pr oce d ures . 
H os pital war d  
O utc o me  
All war ds atte n de d, war d of a d missi o n, war d of 
dia g n osis (s ur gical, me dical, o nc o l o g y, 
he mat ol o g y, i nfecti o us disease, I C U, ot her).  
P h ysicia n s pecialt y  
Site c haracteristic  
Me dical s pecialt y of t he treati n g p h ysicia n (e. g., 
i nfecti o us disease, s ur gical). 
9. 3. 1.  D e y o- C h arls o n C o m or bi dit y In de x  
C o m or bi dit y relate d i nf or mati o n will be c ollecte d fr o m t he me dical rec or ds f or t he patie nts  
(e. g., s oli d t u m or [ yes/ n o], bl o o d s yste m dis or ders, dia betes, h y pert e nsi o n, c hr o nic 
o bstr ucti ve p ul m o nar y disease, r e nal i ns uffici e nc y, etc.). D e y o - C harls o n C o m or bi dit y I n de x 
will be use d t o q ua ntif y c o m or bi dit y, assesse d b y t he i n vesti gat or . Details of D e y o- C harls o n 
C o m or bi dit y I n de x calc ulati o n are pr o vi de d i n A N N E X 4 . 
9. 3. 2.  A P A C H E  II sc ore a n d S O F A sc ore  
F or I C U p atie nts, A P A C H E II a n d S O F A sc ore  will be c ollecte d as pe r I C U r o uti ne practice. 
F or patie nts a d mitte d t o war d  ot her t h a n I C U f or w h o m A P C H E II a n d S O F A sc ore are n ot 
prese nt i n t he me dical rec or ds, it will n ot be calc ulate d f or t his st u d y. Details of A P A C H E II 
sc ore a n d S O F A sc ore calc ulati o n are pr o vi d e d i n A N N E X 5  a n d A N N E X 6.   
9. 3. 3.  P itt B actere mi a S c ore  
T he  disease s e ver it y will als o be q ua ntifie d b y Pitt Bacte re mia Sc ore. T h e i nf or mati o n wi ll 
be c ollecte d fr o m  me dical rec or ds of p atie nts . Det ai ls of Pitt Bacte re mia Sc ore cal c ulati o n 
are pr o vi d e d i n A N N E X 7 . 
9. 3. 4.  S o urce of i nfecti o n  
H os pital- ac q uire d i nfecti o n ( H AI ): are n os o c o miall y ac q uire d i nfecti o ns t hat are t y picall y n ot 
prese nt or mi g ht n ot be i nc u bati n g at t he ti me of a d missi o n. T hese i nfecti o ns are us uall y 
ac q uire d after h os pitalizati o n a n d ma nifest 4 8 h o urs after h os pital a d missi o n.  2 5 
 
C o m m u nit y -ac q uire d i nf ecti o n (C AI ): are i nfecti o ns t hat are  c o ntracte d o utsi de of a h os pital 
or mi g ht be i nc u bati n g at t he ti me of a d missi o n, dia g n ose d wit hi n 4 8 h o urs of h os pital 
a d missi o n wit h o ut a n y pre vi o us healt h care e n c o u nter.  2 5 
9. 3. 5.  I n dic ati o n 
I ndicati o ns i ncl u des: 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 5  of 5 7  
•  cI AI: a cli nical dia g n osis of I AI ( i. e., perit o nitis, i ntra perit o neal a bscess, li ver 
a bscess, pa n creatic a bscess, a p pe n dicitis, di vertic ulitis, gastric or d u o de nal ulcers, 
c h ola n gitis, c h olec ystitis) a n d e vi de nce of i n v ol ve me nt of m ore t ha n 1 or g a n, ca usi n g 
perit o nitis a n d re q uiri n g b ot h s ur gical a n d a nti bi otic t hera p y ( b e y o n d 2 4 h o urs 
re gi me n), as re gister e d i n t he me dical rec or d or rec or d. H os pital-ac q uire d cI AI will be 
defi ne d as cI AI t h at de vel o ps at least 4 8 h o urs after h os pital a d missi o n. Healt hcare-
ass ociate d cI AI will be d efi ne d as cI AI t h at occ urs w hile recei vi n g treat me nt f or ot her 
c o n diti o ns i n a healt hcar e facilit y ( e. g., n ursi n g h o me, l o n g- ter m care, he m o dial ysis 
cli nic, h os pital) wit hi n 3 m o nt hs pri or t o t he i n patie nt a d missi o n or d uri n g t he 
i n patie nt a d missi o n.2 6 
•  
H A P/ V A P: a cli nical dia g n osis of p ne u m o nia a n d e vi de nce of n os oc o mial ori gi n as 
re gistere d i n t he me di cal rec or d . H A P is defi ne d as p ne u m o nia t hat occ urs at least 4 8 
h o urs after h os pital a d missi o n; V A P is defi ne d as p ne u m o nia t hat occ urs at least 4 8 
h o urs after e n d otrac heal i nt u bati o n or trac he ost o m y.  
•  Li mite d Treat me nt O pti o ns ( L T O ) i n dicati o n: a n y i nfecti o n  wit h li mite d treat me nt 
o pti o ns, base d u p o n cli nical or micr o bi ol o gical e vi de nce. 
T he site of i nfecti o n ref ers t o t he ori gi n al or ga n of t he i nfecti o n (e. g., a p pe n di x, bla d der, 
ki d ne y, lar ge i ntesti ne, l u n gs, li ver, gall bla d der, pa ncreas, p erit o ne u m s mall i ntesti ne, 
st o mac h, uret hra, ot h er). 
9. 3. 6.  Micr o bi ol o gic al t est r es ult 
Pat h o ge n s usce pti bilit y: s usce pti bilit y i nf or mati o n will be c ollecte d f or t he is olate d 
pat h o ge ns (e. g. , a mi n o gl yc osi des, β -lacta ms, car b a pe ne ms, ce p hal os p ori ns, gl yc o pe pti des, 
macr oli des, o xaz oli di n o nes, pe nicilli ns, β -lacta mase i n hi bit ors, q ui n ol o nes, tetrac ycli nes, 
ot her). S e nsiti vit y t o eac h a nti bi otic (s usce pti ble, i nter me diate, resista nt)  will be c ollecte d . 
F or C R E strai ns, t he c orr es p o n di n g e nz y me t y pe a n d ge n ot y pe m o nit ori n g res ults fr o m l ocal 
la b will als o be c ollecte d.  
M ulti dr u g- resista nce: T h e is olate is n o n-s usce pti ble t o at least 1 a ge nt i n ≥3 a nti micr o bial 
cate g ories, e xcl u di n g a nti bi otic classes t o w hic h t he pat h o ge n is i ntri nsicall y resista nt.2 7  
Car ba pe n e m resista nce is defi ne as is o lates resista nt t o a n y of t he car ba pe n e ms of i mi pe ne m, 
mer o pe ne m, erta pe n e m , or d ori pe ne m. 
9. 3. 7.  E m piric t her a p y a n d defi niti ve t her a p y  
T he e m piric or d efi niti ve usa ge of c eftazi di me-a vi bacta m  will be  rec or de d b y i n vesti gat ors 
base d o n cli nical pr actice  a n d me dical rec or d s. E m piric t hera p y will be  d efi ne d as t hera p y 
e m pl o ye d pri or t o release of micr o bi ol o gical test res ults ( pat h o ge n i de ntifie d), w hereas 
defi niti ve t hera p y will be  defi ne d as t hera p y gi ve n after releas e of micr o bi ol o gical test res ults 
( pat h o ge n i de ntifie d).  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 6  of 5 7  
9. 3. 8.  Cli nic al a n d micr o bi ol o gic al o utc o me e v al u ati o n 
T he e val uati o n criteria of cli nical a n d micr o bi ol o gical o utc o me is descri b e d  i n A N N E X 3 .   
9. 4.  D at a s o urces   
T he st u d y data s o urce will be me dical rec or ds fr o m t he cli nical researc h ce ntres  a n d 
micr o bi ol o gical res ult  fr o m t he ce ntral la b. 
T he i nf or mati o n fr o m me dical rec or d will be rec or de d b y t he i n vesti gat or i n electr o nic C R F 
(e C R F). V aria bles a n d data a bstract e d fr o m me dical rec or d are  descri be d i n Ta ble  1. 
P re-treat me nt micr o bi ol o g y sa m ple a n d res ult, a n d p ost-treat me nt micr o bi ol o g y sa m ple a n d 
res ult will be c ollecte d fr o m la b orat or y rec or ds w he n a vaila ble, a n d micr o bi ol o gic al o utc o me 
a n d t he fail ur e reas o n.  
T he micr o bi ol o gic al o utc o me a n d t he fail ure reas o n will be o btai ne d fr o m ce ntral la b 
i n vesti gat or assess me nt. 
9. 5.  St u d y size  
Sa m ple size f or t his st u d y was calc ul ate d wit h t he g oal of ma xi mizi n g precisi o n  (c o nfi de nce 
i nter val [CI ]) w he n esti m ati n g cli nical a n d micr o bi ol o gical treat me nt s uccess.  4 5 0 eli gible 
patie nts will be e nr olle d.  
Cli nical S uccess Ass u m pti o ns:  
•  C o nsi deri n g all data l ost d ue t o all ki n ds of reas o ns, 6 2. 5 % of eli gi ble patie nts are  
assessa ble f or cli nical  o utc o me (s uccess or fail ure) . 
•  6 5 % of t he assess a ble patie nts e x perie n ce cli nical  treat me nt s uccess. 
 
Micr o bi ol o gical S uccess Ass u m pti o ns: 
•  C o nsi deri n g all data l ost d ue t o all ki n ds of reas o ns, 5 0 % of eli gi ble patie nts are 
assessable f or micr o bi ol o gical o utc o me. 
•  7 5 % of t he assess a ble patie nts e x perie n ce micr o bi ol o gical s uccess.  
 
Ta ble  2 dis pla ys t he precisi o n of eac h esti mate ( 9 5 % CI), f or differe nt rate of cli nical a n d 
micr o bi ol o gical s uccess  a n d sa m ple sizes ra n gi n g fr o m 2 0 0 t o 3 5 0 e val ua ble patie nts.  
Ass u mi n g cli nical s uccess rate is 6 5 % a n d 2 8 0 p atie nts (a b o ut 6 2. 5 % of 4 5 0  patie nts) are 
e val ua ble after e nr olli n g 4 5 0 eli gi ble patie nts, t he prec isi o n of cli nical s u ccess rate is 5 9. 4 % 
a n d 7 0. 6 %, i.e., t he wi dt h of 9 5 % CI is 1 1. 2 %. Ass u mi n g micr o bi ol o gical s uccess rate is 
7 5 % a n d 2 2 0 patie nts (a b o ut 5 0 % of 4 5 0 patie nts) are e v a l ua ble after e nr olli n g 45 0 eli gi ble 
patie nts, t he precisi o n of micr o bi ol o gical s uccess rate is 6 9. 3 % a n d 8 0. 7 %, i.e., t he wi dt h of 
9 5 % CI is 1 1. 4 %.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 7  of 5 7  
T a ble 2. 
Precisi o n of t he esti m ate ( 9 5 % CI) f o r d iffere nt cli nic al a n d 
micr o bi ol o gic al s uccess r ates a n d n u m ber of e v al u a bl e p atie nts  
N u m ber of 
E v al u a ble 
P atie nts  
Cli nic al a n d Micr o bi ol o gic al S uccess R ate  ( %) 
6 0  
6 5  
7 0  
7 5  
8 0  
2 0 0  
( 5 3. 2, 6 6. 8) 
( 5 8. 4, 7 1. 6) 
( 6 3. 6, 7 6. 4) 
( 6 9. 0, 8 1. 0) 
( 7 4. 5, 8 5. 5) 
2 2 0  
(5 3. 5, 6 6. 5 ) 
( 5 8. 7, 7 1. 3) 
( 6 3. 9, 7 6. 1)  
( 6 9. 3, 8 0. 7) 
( 7 4. 7, 8 5. 3) 
2 4 0  
( 5 3. 8, 6 6. 2 ) 
( 5 9. 0, 7 1. 0) 
( 6 4. 2, 7 5. 8) 
( 6 9. 5, 8 0. 5) 
( 7 4. 9, 8 5. 1) 
2 6 0  
( 5 4. 0, 6 6. 0) 
(5 9. 2, 7 0. 8)  
( 6 4. 4, 7 5. 6) 
( 6 9. 7, 8 0. 3) 
( 7 5. 1, 8 4. 9) 
2 8 0  
( 5 4. 3, 6 5. 7) 
( 5 9. 4, 7 0. 6) 
( 6 4. 6, 7 5. 4) 
( 6 9. 9, 8 0. 1) 
( 7 5. 3, 8 4. 7) 
3 0 0  
( 5 4. 5, 6 5. 5) 
( 5 9. 6, 7 0. 4) 
( 6 4. 8, 7 5. 2) 
( 7 0. 1, 7 9. 9) 
( 7 5. 5, 8 4. 5) 
3 2 0  
(5 4. 6, 6 5. 4 ) 
( 5 9. 8, 7 0. 2) 
( 6 5. 0, 7 5. 0) 
( 7 0. 3, 7 9. 4) 
( 7 5. 6, 8 4. 4) 
3 5 0  
(5 4. 9, 6 5. 1 ) 
( 6 0. 0, 7 0. 0) 
( 6 5. 2, 7 4. 8) 
( 7 0. 5, 7 9. 5) 
( 7 5. 8, 8 4. 2) 
 
9. 6.  D at a m a n a ge m e nt 
Detaile d data ma n a ge me nt re q uire me nt a n d t o ols are d oc u m e nte d i n t he D ata Ma na g e me nt 
Pla n.  
9. 6. 1.  C ase re p ort f or ms  ( C R Fs)/ D at a c ollecti o n t o ols ( D C Ts)/ Electr o nic d at a rec o r d 
As use d i n t his pr ot oc ol, t he ter m C R F s h o ul d be u n derst o o d t o refer t o eit her a pa p er f or m or 
a n electr o ni c data r ec or d or b ot h, de pe n di n g o n t he data c ollecti o n met h o d use d i n t his st u d y. 
All partici pa nt data r elati n g t o t he st u d y will be rec or de d o n pri nte d or electr o nic C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e. g., la b orat or y d ata). T he i n vesti gat or 
is res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F. 
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n G ui da nce. 
A C R F is re q uire d a n d s h o ul d be c o m plete d f or eac h i ncl u de d patie nt. T he c o m plete d 
ori gi nal C R Fs are t he s ol e pr o pert y of Pfi zer a n d s h o ul d n ot be ma de a vaila ble i n a n y f or m t o 
t hir d parties, e xce pt f or a ut h orize d re prese nt ati ves of Pfizer or a p pr o pri ate re g ulat or y 
a ut h orities, wit h o ut writte n per missi o n fr o m Pfizer. T he i n vesti gat or s hall e ns ure t hat t he 
C R Fs are sec urel y st or e d at t he st u d y site i n  e ncr y pte d electr o nic a n d / or pa per f or m a n d will 
be pass w or d pr ot ecte d t o pre ve nt access b y u n a ut h orize d t hir d parties. 
T he i n ves ti gat or has ulti mate res p o nsi bilit y f or t he c ollecti o n a n d re p orti n g of all cli nical, 
safet y, a n d la b orat or y d ata e nter e d o n t he C R Fs a n d a n y ot her data c ollecti o n f or ms (s o urce 
d oc u me nts) a n d e ns uri n g t hat t he y are acc urate, a ut he ntic/ ori gi nal, attri b uta b le, c o m plete, 
c o nsiste nt, le gi ble, ti mel y (c o nte m p ora n e o us), e n d uri n g, a n d a vaila ble w h e n re q uire d. T he 
C R Fs m ust be si g ne d b y t he i n vesti gat or or b y a n a ut h orize d staff me m ber t o attest t hat t he 
data c o ntai ne d o n t h e C R Fs ar e tr ue. A n y c orrecti o ns t o e ntries ma de i n t he C R Fs or s o urce 
d oc u me nts m ust be date d, i nitiale d, a n d e x plai ne d (if necessar y) a n d s h o ul d n ot o bsc ure t he 
ori gi nal e ntr y. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 8  of 5 7  
I n m ost cases, t he s o ur ce d oc u me nts are t h e h os pital or t he p h ysicia n's c h art. I n t hes e cases, 
data c ollecte d o n t h e C R Fs m ust matc h t h ose c harts.  
I n s o me cases, t h e C R Fs ma y als o ser ve as t he s o urce d oc u m e nt. I n t hese cases, a d oc u me nt 
s h o ul d be a vaila ble at t he i n vesti gat or site a n d at Pfizer t hat clearl y i de ntifies t h ose data t hat 
will be rec or d e d o n t he C R F s, a n d f or w hi c h t he C R Fs will sta n d as t he s o urce d oc u m e nt. 
9. 6. 2.  Rec or d rete nti o n  
T o e na ble e v al uati o ns a n d/ or i ns pecti o ns/a u dits fr o m re g ulat or y a ut h orities or Pfizer, t he 
i n vesti gat or a grees t o kee p rec or ds, i ncl u di n g t he i de ntit y of all partici pati n g patie nts 
(s ufficie nt i nf or m ati o n t o li n k rec or ds, e. g., C R Fs a n d h os pital rec or ds), all ori gi nal si g ne d 
i nf or me d c o nse nt d oc u m e nts, c o pies of all C R Fs, safet y re p orti n g f or ms, s o urce d oc u m e nts, 
detaile d rec or ds of tr eat me nt dis p ositi o n, a n d a de q uate d oc u me ntati o n of rele v a nt 
c orres p o n d e nce ( e. g., lett ers, meeti n g mi n utes, a n d tele p h o ne call re p orts). T he rec or ds 
s h o ul d be retai ne d b y t he i n vesti gat or acc or di n g t o l ocal re g ulati o ns or as s p ecifie d i n t he 
cli nical st u d y a gree me nt ( C S A), w hic he ver is l o n ger. T he i n vesti gat or m ust e ns ure t hat t he 
rec or ds c o nti n ue t o be st ore d sec urel y f or s o l o n g as t he y are retai n e d. 
If t he i n vesti gat or bec o m es u na ble f or a n y reas o n t o c o nti n ue t o retai n st u d y rec or ds f or t he 
re q uire d p eri o d (e. g., retire me nt, rel o cati o n), Pfizer s h o ul d be pr os pecti vel y n otifie d.  T he 
st u d y rec or ds m ust be tra nsferr e d t o a desi g nee acce pta ble t o Pfizer, s uc h as a n ot her 
i n vesti gat or, a n ot her i nstit uti o n, or t o a n i n de pe n de nt t hir d part y arra n ge d b y Pfizer.  
I n v esti gat or rec or ds m ust be ke pt f or a mi ni m u m of 1 5 years after c o m pleti o n or 
disc o nti n uati o n of t he st u d y or as re q uire d b y a p plica ble l ocal re g ulati o ns.  
T he i n vesti gat or m ust o btai n Pfizer's writte n per missi o n bef ore dis p osi n g of a n y rec or ds, 
e ve n if r ete nti o n re q uir e me nts ha ve bee n m et. 
9. 7.  D at a a n al ysis  
D etaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of d ata c ollect e d i n t his  st u d y will 
be d oc u me nte d i n a statistical a nal ysis p la n ( S A P), w hic h will be date d, file d a n d mai ntai ne d 
b y t he s p o ns or. T he S A P ma y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y maj or 
m o dificati o ns of pri mar y e n d p oi nt defi niti o ns or t heir a nal yses w o ul d be reflecte d i n a 
pr ot oc ol a me n d me nt.  
9. 7. 1.  A n al ysis set s 
•  F ull A nal ysis Set  ( F AS): 
T he F A S will i ncl u de all e nr olle d patie nts. T he e nr olle d patie nts s h o ul d meet t he 
criteria i n Secti o n 9. 2. 1  a n d Secti o n 9. 2. 2 . 
•  Cli nicall y  E val ua ble ( C E) A nal ysis Set : 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 2 9  of 5 7  
T he C E s et will i ncl u de all patie nts fr o m t he F A S  wit h  at least 7 2 h o urs use of 
ceftazi di me-a vi bacta m  a n d at least 1 n o n-missi n g cli nical e val uati o n o u tc o me.  
•  Mic r o bi ol o gicall y E val ua ble ( M E) A n al ysis Set : 
T he M E set will i ncl u de all patie nts fr o m t he F A S  wit h at least 7 2 h o urs use of 
ceftazi di me-a vi bacta m  a n d at least 1 n o n- missi n g micr o bi o l o gical e val uati o n 
o utc o me. 
9. 7. 2.  A n al ysis of t he pri m ar y e n d p oi nt  
T he cli nical o utc o me will be s u m mar ize d i n C E A nal ysis S et. 
T he micr o bi ol o gical o utc o me a n d its s u bcate g or y will be s u m marize d o verall a n d b y 
pat h o ge ni n M E A nal ysis Set  A nal ysis Set. T he micr o bi ol o gical o utc o me will als o be 
s u m marize d base d o n t h e e val uati o n b y site i n vesti gat or a n d t he ce ntral la b, res pecti vel y. 
T he micr o bi ol o gical fail ure reas o n will be s u m marize d i n M E  A nal ysis Set. 
I n dicati o n, t y pe of i nfecti o n, site of i nfecti o n a n d s o urce of i nfecti o n f or t h e i nitial 
ceftazi di me-a vi bacta m  will be s u m marize d i n t he F A S .    
T he i de ntifie d pat h o ge n, s usce pt i bility, ge n ot y pe a n d t y pe of e nz y me at bas eli ne will be 
s u m marize d i n F AS. 
9. 7. 3.  A n al ysis of t he sec o n d ar y e n d p oi nt  
Sec o n dar y e n d p oi nts will be s u m marize d i n b ot h F A S a n d C E A nal ysis Set.  
S u m marize t he  d ose  a n d fre q uen c y,  of ceftazi di me-a vi bact a m . S u m marize t he c o m bi nati o n 
t hera p y wit h ceftazi di me -a vi bacta m  b y t hera p y n a me. 
T he L O S a n d I C U L O S will be s u m marize d usi n g descri pti ve statistics . 
T he a d miss i o n dia g n osis, disc har ge dia g n osis a n d baseli ne dia g n osis at i nitiati n g 
ceftazi di me-a vi bacta m  will be s u m marize d.  
T he c o nc o mita nt pr o ce d ures will be s u m marize d b y preferre d t er m  defi n e d b y Me dical 
Dicti o nar y f or Re g ul at or y Acti vities ( Me d D R A ). 
T he le n gt h of mec h a nical ve ntilati o n  will be s u m marize d usi n g des cri pti ve statistics.  
T he rate of rea d missi o n d ue t o rec urre n ce of i nfecti o n ha p pe ne d i n t he sa me l ocati o n 3 0 a n d 
6 0 da ys after disc har g e will be s u m marize d.  
T he m ortalit y i n h os pital will be s u m marize d.  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 0  of 5 7  
9. 7. 4.  A n al ysis of t he c o v ari at es 
All c o variates  will be s u m marize d usi n g descri pti ve statistics.  
9. 8.  Q u alit y c o ntr ol 
T he i n vesti gat or m ust per mit st u d y relate d m o nit ori n g , a u dits, I R B/IE C re vie w, a n d pr o vi de 
direct access t o s o urce data d oc u me nts . T his verifi cati o n ma y als o occ ur aft er st u d y 
c o m pleti o n. It is i m p orta nt t hat t he i n vesti gat or(s) a n d t heir rel e va nt pers o n nel are a vaila ble 
d uri n g t he m o nit ori n g visits a n d p ossi ble a u dits or i ns pecti o ns a n d t hat s uffi cie nt ti me is 
de v ote d t o t he pr ocess. 
St u d y m o nit ors will perf or m o n g oi n g s o urc e data verificati o n t o c o nfir m t hat data e ntere d 
i nt o t he C R F b y a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce 
d oc u me nts; t hat t he ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g 
c o n d ucte d i n acc or d a nce wit h t he c urre ntl y a p pr o v e d pr ot oc ol a n d a n y ot h er st u d y 
a gree m e nts, a n d all a p pli ca ble r e g ulat or y re q uire me nts. 
M o nit ori n g details descri bi n g strate g y, i ncl u di n g defi niti o n of st u d y critical data ite ms a n d 
pr ocesses, met h o ds, r es p o nsi bilities, a n d re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce 
iss ues a n d m o nit ori n g tec h ni q ues (ce ntral, virt ual, or o n site m o nit ori n g), are pr o vi de d i n t he 
D ata M a na g e me nt P la n, a n d M o nit ori n g a n d Data Q ualit y O versi g ht Pla n mai ntai ne d a n d 
utilize d b y t he s p o ns or or desi g nee.  
T he s p o ns or or desi g nee is res p o nsi ble f or t he dat a ma na ge m e nt of t his st u d y, i ncl u di n g 
q ualit y c hec ki n g of t he d ata. 
T he i n vesti gat or(s) will n otif y t he s p o ns or or its a ge nts i m me diatel y of a n y fi n di n gs a b o ut t he 
q ualit y of t he st u d y. 
9. 9.  Li mit ati o n s of t he rese arc h met h o ds  
T here are s o me li mitati o ns i n t his st u d y. First  of all, beca use dat a will be c ollecte d via  
me dical  rec or d, it is li kel y t hat s o me of t he re q u este d i nf or mati o n will be missi n g, 
i nc o m plete, or i nacc urate. Safe g uar ds a gai nst missi n g a n d i nacc urate dat a will be e m pl o ye d 
t hr o u g h o ut t he researc h pr ocess, w hic h i n cl u de c h o osi n g q ualifie d sites, e ns uri n g pri mar y 
varia bles of i nterest t hat are r o uti nel y c ollecte d, usi n g vali date d e C R Fs a n d C R F c o m pleti o n 
g ui deli ne, w he n a p pr o pri ate. 
Sec o n d l y, it is p ossi ble t hat t his st u d y will ha ve a selecti o n bias. F or e xa m ple, patie nts treate d 
i n selecte d tertiar y h os pitals i n o ur st u d y ma y li kel y t o ha ve m ore se v ere dis ease s a n d 
recei v e d better s u p p orti ve car e c o m pare d t o t h ose w h o atte n d s maller tertiar y care facilities 
or l o wer le v el car e  f acilities. T hese ma y li mit t he ge neraliza bilit y of st u d y res ults t o re pres e nt 
t he use of ceftazi di me-a vi bacta m  i n C hi na. T heref ore, o ur st u d y res ults will be i nter pret e d 
wit hi n st u d y setti n g c o nte xt. Als o, baseli ne ch aracteristics of e nr olle d p atie nts i n t he st u d y 
will be s u m marize d a n d c o m pare d t o ot her st u dies t o e val uate t he p ote ntial effects. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 1  of 5 7  
Fi nall y, o utc o me misclassificati o n ma y occ ur i n t his st u d y. Patie nts will be f oll o we d f or 3 0 
a n d 6 0 da ys aft er h os pit al disc har ge. It will be  diffic ult t o disti n g uis h patie nts w h o were l ost 
t o f oll o w- u p fr o m t h ose w h o wer e rea d mitte d at a differe nt h ealt hcare facilit y. T his ma y 
res ult i n a n u n deresti mat e of s o me o utc o mes.  
9. 1 0.  Ot her as pects  
N ot a p plica ble 
1 0.  P R O T E C TI O N O F H U M A N  S U B J E C T S  
1 0. 1.  P atie nt i nf or m ati o n  
All parties will c o m pl y wit h all a p plica ble la ws, i n cl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of p atie nt pers o nal data. S uc h 
meas ures will i ncl u de o mitti n g patie nt na mes or ot her directl y i de ntifia ble data i n a n y 
re p orts, p u blicati o ns, or ot her discl os ures, e x ce pt w here re q uire d b y a p plica ble la ws. 
T he pers o nal d ata will be st ore d at t he st u d y site i n  e ncr y pte d electr o nic a n d/ or pa per  f or m 
a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y a ut h orize d 
st u d y staff ha ve access. T he st u d y site will i m ple me nt a p pr o priate t ec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he p ers o nal data ca n b e rec o vere d i n t he e ve nt of 
disaster. I n t he e v e nt of a p ote ntial pers o nal data breac h, t h e st u d y site s hall be res p o nsi ble 
f or deter mi ni n g w het h er a pers o nal d ata breac h h as i n fact occ urre d a n d, if s o, pr o vi di n g 
breac h n otifi cati o ns as re q uire d b y la w. 
T o pr otect t he ri g hts a n d free d o ms of n at ural pers o ns re gar di n g t he pr ocessi n g of pers o nal 
data, w he n st u d y data ar e c o m pile d f or tra nsfer t o Pfizer a n d ot her a ut h orize d parties, patie nt 
na mes will be re m o ve d a n d will be re place d b y a si n gle, s pecific, n u meri cal c o de, base d o n a 
n u m beri n g s yste m defi ne d b y Pfizer. All ot her i de ntifia ble data tra nsferre d t o Pfizer or ot her 
a ut h orize d parties will be i de ntifie d b y t his si n gle, patie nt- s pecific c o de. T h e i n vesti gat or site 
will mai ntai n a c o nfi de ntial list of patie nts w h o partici pate d i n t he st u d y, li n k i n g eac h 
patie nt’s n u merical c o de t o his or her act ual i de ntit y. I n case of data tra nsfer, Pfizer will 
mai ntai n hi g h sta n dar ds of c o nfi de ntialit y a n d pr otecti o n of patie nts’ pers o nal data c o nsiste nt 
wit h t he cli nical st u d y agree me nt  a n d a p plica ble pri vac y la ws.  
1 0. 2.  P atie nt  co nse nt  
T he i nf or me d c o ns e nt /asse nt doc u me nts a n d a n y patie nt recr uit me nt materials m ust be i n 
c o m plia nce wit h l ocal r e g ulat or y re q uire m e nts a n d le gal re q uire me nts, i ncl u di n g a p plica ble 
pri vac y la ws.  
T he i nf or me d c o ns e nt /asse nt d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess a n d a n y 
patie nt recr uit me nt materials m ust be re vie we d a n d a p pr o ve d b y Pfizer, a p pr o ve d b y t he 
I R B/I E C bef ore use , a n d a vaila ble f or i ns pecti o n. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 2  of 5 7  
T he i n vesti gat or m ust e ns ure t hat eac h st u d y patie nt, or his or her le gall y acce pta bl e 
re pres e ntati ve, is f ull y i nf or me d a b o ut t he n at ure a n d o bjecti ves of t he st u d y, t he s hari n g of 
data relati n g t o t he st u d y a n d p ossi ble ris ks ass oci ate d wit h partici pati o n, i ncl u di n g t he ris ks 
ass ociate d wit h t he pr o cessi n g of t he patie nt’s pers o nal data. T he i n vesti gat or f urt her m ust 
e ns ure t hat eac h st u d y patie nt or his or her le gall y acce pta ble re pres e ntati ve, is f ull y i nf or me d 
a b o ut his or her ri g ht t o access a n d c orrect his or h er pers o n al data a n d t o wit h dra w c o nse nt 
f or t he pr ocessi n g of his or her pers o nal data. 
W he ne v er c o ns e nt is o btai ne d fr o m a p atie nt’ s le g all y acce pta ble re pres e ntati ve, t he patie nt’s 
asse nt (affir mati ve a gree me nt) m ust s u bse q ue ntl y be o btai ne d w he n t h e patie nt has t he 
ca pacit y t o pr o vi de asse nt, as deter mi ne d b y t he I R B/I E C. If t he i n vesti gat or deter mi nes t hat 
a patie nt’s decisi o nal ca p acit y is s o li mite d t hat he or s he ca n n ot reas o n a bl y be c o ns ulte d, 
t he n, as per mitte d b y t he I R B/I E C a n d c o nsiste nt wit h l ocal re g ulat or y a n d le gal 
re q uire me nts, t he p atie nt’s asse nt ma y be w ai ve d wit h s o urce d oc u me nt ati o n of t he reas o n 
asse nt was n ot o btai ne d. If t he st u d y patie nt d oes n ot pr o vi de his or her o w n c o nse nt, t he 
s o urce d oc u m e nts m ust rec or d w h y t he patie nt di d n ot pr o vi de c o nse nt (e. g., mi n or, 
decisi o nall y i m paire d a d ult), h o w t he i n vesti gat or deter mi ne d t hat t he pers o n si g ni n g t he 
c o nse nt was t he p atie nt’s le gall y acce pta ble re pres e ntati ve, t he c o nse nt si g n er’s relati o ns hi p 
t o t he st u d y patie nt (e. g., pare nt, s p o use), a n d t hat t he patie nt’s asse nt w as o btai ne d or 
wai v e d. If asse nt is o btai ne d ver ball y, it m ust be d oc u me nte d i n t he s o urce d oc u me nts.  
T he i n vesti gat or, or a p ers o n desi g nate d b y t he i n v esti gat or, will o btai n writte n i nf or me d 
c o nse nt fr o m eac h patie nt or t he patie nt’s le gall y acce pta bl e re prese ntati ve bef o re a n y 
st u d y-s pecific acti vit y is perf or me d u nl ess a w ai ver of i nf or m e d c o nse nt h as bee n gra nte d b y 
a n I R B/I E C. T he i n v esti gat or will retai n t he ori gi n al of eac h patie nt's si g ne d c o nse nt/ asse nt 
d oc u me nt. 
1 0. 3.  P atie nt wit h dr a w al    
Patie nts  ma y wit h dra w fr o m t he st u d y at a n y ti me at t heir o w n re q u est, or t he y ma y be 
wit h dra w n at a n y ti me at t he discreti o n of t he i n vesti gat or or s p o ns or f or safet y, be ha vi oral, 
or a d mi nistrati ve reas o ns. I n a n y circ u msta nce, e v er y eff ort s h o ul d be ma d e t o d oc u me nt 
patie nt o utc o me, i f a p plica ble. T he i n vesti gat or w o ul d i n q uire a b o ut t he reas o n f or 
wit h dra wal a n d f oll o w- u p wit h t he patie nt re gar di n g a n y u nres ol ve d a d vers e e ve nts. 
If t he patie nt  wit h dra ws fr o m t he st u d y, a n d als o wit h dra ws c o nse nt f or discl os ure of f ut ure 
i nf or mati o n, n o f urt her e val uati o ns s h o ul d be perf or me d, a n d n o a d diti o nal data s h o ul d be 
c ollecte d. T he s p o ns or ma y retai n a n d c o nti n ue t o use a n y data c ollecte d b ef ore s uc h 
wit h dra wal of c o nse nt. 
1 0. 4.  I nstit uti o n al re vie w bo ar d (I R B)/I n de pe n de n t et hics co m mittee (I E C)  
It is t he r es p o nsi bilit y of t he i n vesti gat or t o ha ve pr os pecti ve a p pr o val of t h e st u d y pr ot oc ol, 
pr ot oc ol a me n d me nts, a n d i nf or me d c o nse nt f or ms, a n d ot her rel e va nt d oc u me nts, 
(e. g., recr uit me nt a d vertise me nts), if a p plica bl e, fr o m t he I R B/I E C. All c orres po n de nce wit h 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 3  of 5 7  
t he I R B/I E C s h o ul d be r etai ne d b y t he i n vesti gat or. C o pies of I R B/I E C a p pr o vals s h o ul d be 
f or war de d t o Pfizer. 
1 0. 5.  Et hic al c o n d uct of t he st u d y  
T he st u d y will be c o n d ucte d i n acc or d a nce wit h le gal a n d re g ulat or y re q uire me nts, as well as 
wit h scie n tific p ur p ose, v al ue a n d ri g or a n d f oll o w ge nerall y acce pte d res earc h practices 
descri be d i n G ui deli nes f or G o o d P har mac o e pi de mi ol o g y Practices, G o o d Practices f or 
O utc o mes Researc h iss ue d b y t he I nter nati o nal S o ciet y f or P har mac oec o n o mics a n d 
O utc o mes Researc h  (I S P O R), G o o d practices f or real- w orl d data st u dies of treat me nt a n d/ or 
c o m parati ve eff ecti ve ness: Rec o m me n dati o ns fr o m t he j oi nt I S P O R –I nter nati o nal S ociet y f or 
P har mac oe pi de mi ol o g y ( I S P E) S peci al Tas k F orce o n real -w orl d e vi de n ce i n healt h care 
dec isi o n ma ki n g, I nter nati o nal Et hical G ui deli nes f or E pi de mi ol o gical St u dies iss ue d b y t he 
C o u ncil f or I nter nati o nal Or ga nizati o ns of M e dical Scie nces, E ur o p ea n Me dici nes A ge nc y 
( E M A) E ur o p ea n N et w or k of Ce ntres f or P har mac oe pi de mi ol o g y a n d P har mac o vi gila nce 
( E N Ce P P) G ui de o n Met h o d ol o gical Sta n dar ds i n P har mac oe pi de mi ol o g y, T he E N Ce P P 
C o de of C o n d uct f or scie ntific i n de pe n de nce a n d tra ns pare nc y i n t he c o n d u ct of 
p har mac o e pi de mi ol o gical a n d p har mac o vi gila n ce st u dies, a n d F o o d a n d Dr u g 
A d mi nistrati o n ( F D A) G ui da nce f or I n d ustr y: G o o d P har mac o vi gila nce Practices a n d 
P har mac oe pi de mi ol o gic Assess me nt.  
1 1.  M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S R E Q UI R E M E N T S  
1 1. 1.  S afet y re p orti n g f or pri m ar y d at a c ollecti o n 
Data fr o m ce ntral la b ass ess me nt will be pri m ar y data c ollecti o n. Re p orti n g of safet y e v e nt 
i de ntifie d d uri n g ce ntr al la b assess me nt will f oll o w t he i nstr ucti o ns bel o w. 
R E Q UI R E M E N T S  
T he ta ble bel o w s u m mari zes t he r e q uire me nts f or rec or di n g safet y e ve nts o n t he C R F a n d f or 
re p orti n g saf et y e ve nts o n t he NI S a d vers e e v e nt m o nit ori n g ( A E M) Re p ort F or m t o Pfizer 
Safet y. T hese re q uire m e nts are deli neate d f or t hree t y pes of e v e nts: ( 1) seri o us a d verse 
e ve nts ( S A Es); ( 2) n o n-s eri o us a d vers e e v e nts ( A Es ) (as a p plica ble); a n d ( 3) sce nari os 
i n v ol vi n g dr u g e x p os ure, i ncl u di n g e x p os ure d uri n g pre g na nc y, e x p os ure d uri n g breast 
fee di n g, me dicati o n err or, o ver d ose, mis use, e xtra vasati o n, lac k of efficac y, a n d occ u p ati o nal 
e x p os ure. T hes e e v e nts are defi n e d i n t he secti o n “ Defi niti o ns of safet y e v e nts”. 
S afet y e ve nt 
Rec or de d o n t he C R F  
Re p orte d o n t he NI S A E M 
Re p ort F or m t o Pfizer S afet y 
wit hi n 2 4 h o urs of a w are ness  
S A E  
All  
All  
N o n -seri o us A E 
All  
All  
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 4  of 5 7  
S afet y e ve nt 
Rec or de d o n t he C R F  
Re p orte d o n t he NI S A E M 
Re p ort F or m t o Pfizer S afet y 
wit hi n 2 4 h o urs of a w are ness  
Sce nari os i n v ol vi n g e x p os ure t o a 
dr u g u n der st u d y, i ncl u di n g e x p os ure 
d uri n g pre g na nc y, e x p os ure d uri n g 
breast fee di n g, me dicati o n err or, 
o ver d ose, mis use, e xtra vasati o n, lac k 
of efficac y, a n d occ u pati o nal 
e x p os ure 
All (re gar dless of w het her 
ass ociate d wit h a n A E), 
e xce pt occ u p ati o n al 
e x p os ure   
All (re gar dless of w het her 
ass ociate d wit h a n A E)  
N ote: A n y ass ociate d A E is 
re p orte d t o get her wit h t he e x p os ure 
sce nari o. 
 
F or eac h A E, t h e i n vesti gat or m ust p urs ue a n d o bt ai n i nf or mati o n a de q u ate b ot h t o deter mi ne 
t he o utc o me of t he A E  a n d t o assess w het her it m eets t he criteria f or classificati o n as a S A E 
(ref er t o secti o n " Seri o us A d verse E v e nts” bel o w). 
Safet y e ve nts liste d i n t he ta ble a b o v e m ust be re p orte d t o Pfizer wit hi n 2 4 h o urs of 
a war e ness of t he e ve nt b y t he i n vesti gat or  re g a r dless of w het her t he e ve nt is deter mi ne d 
b y t he i n vesti g at or t o be rel at e d t o ceft azi di me- a vi b act a m. I n partic ular, if t he S A E is 
fatal or life-t hreat e ni n g, n otificati o n t o Pfizer m ust be ma de i m me diatel y, irres pecti ve of t he 
e xte nt of a vaila bl e e ve nt i nf or mati o n. T his ti mefra me als o a p plies t o a d diti o nal ne w (f oll o w-
u p) i nf or mati o n o n pre vi o usl y f or war d e d safet y e ve nt re p orts. I n t he rare sit uati o n t hat t he 
i n vesti gat or d oes n ot bec o me i m me diatel y a ware of t he occ urre n ce of a safet y e ve nt, t he 
i n vesti gat or m ust re p ort t he e ve nt wit hi n 2 4 h o urs after lear ni n g of it a n d d o c u me nt t he ti me 
of his/ her first a w are n ess of t he e ve nts.  
F or safet y e ve nts t hat are c o nsi dere d seri o us or t hat are i de ntifie d i n t he far ri g ht c ol u m n of 
t he ta ble a b o ve t h at are r e p orta ble t o Pfizer wit hi n 2 4 h o urs of a w are n ess, t he i n vesti gat or is 
o bli gate d t o p urs ue a n d t o pr o vi de a n y a d diti o nal i nf or mati o n t o Pfizer i n acc or da n ce wit h 
t his 2 4- h o ur ti mefra me.  I n a d diti o n, a n i n vesti gat or ma y be re q ueste d b y Pfizer t o o btai n 
s pecific f oll o w- u p i nf or mati o n i n a n e x pe dite d fas hi o n. T his i nf or mati o n is m ore detaile d 
t ha n t hat rec or de d o n t he C R F. I n g e neral, t his will i ncl u de a descri pti o n of t he A E i n 
s ufficie nt detail t o all o w f or a c o m plet e me dical assess me nt of t he cas e a n d i n de pe n de nt 
deter mi nati o n of p ossi ble ca usalit y. A n y i nf or mati o n rele va nt t o t he e v e nt, s uc h as 
c o nc o mita nt me dicati o ns a n d ill nesses, m ust be pr o vi de d. I n t he cas e of a p atie nt deat h, a 
s u m mar y of a vaila ble a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer or its 
desi g nate d re prese nt ati ve.  
Re p orti n g peri o d  
F or eac h patie nt, t he s afet y e ve nt re p orti n g peri o d be gi ns at t he ti me of t he patie nt’s first d ose 
of ceft azi di me-a vi b acta m  or t he ti me of t he patie nt’s i nf or me d c o ns e nt if s/ he is bei n g treate d 
wit h ceftazi di me-a vi bact a m  at st u d y start,  a n d lasts t hr o u g h t he e n d of t he o bser vati o n peri o d 
of t he st u d y, w hic h m ust i ncl u de at least 2 8 cale n d ar da ys f oll o wi n g t he last a d mi nistrati o n of 
a dr u g u n der st u d y; a re p ort m ust be s u b mitte d t o Pfizer Safet y ( or its desi g nate d 
re pres e ntati ve) f or a n y of t he t y pes of safet y e ve nts liste d i n t he ta ble a b o ve occ urri n g d uri n g 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 5  of 5 7  
t his peri o d. If a patie nt w as a d mi nistere d a dr u g u n der st u d y o n t he last da y of t he 
o bser vati o n peri o d, t he n t he re p orti n g peri o d s h o ul d be e xte n de d f or 2 8 cale n dar da ys 
f oll o wi n g t he e n d of o bser vati o n. M ost ofte n, t he d ate of i nf or me d c o nse nt is t he sa me as t he 
date of e nr oll me nt. I n s o me sit uati o ns, t here ma y be a la g bet w ee n t he d ates of i nf or me d 
c o nse nt a n d e nr oll me nt. I n t hese i nsta nces, if a patie nt pr o vi des i nf or me d c o nse nt b u t is ne ver 
e nr olle d i n t he st u d y (e. g., patie nt c ha n ges his/ her mi n d a b o ut partici pati o n), t he re p orti n g 
peri o d e n ds o n t he dat e of t he decisi o n t o n ot e nr oll t he patie nt. 
If t he i n vesti gat or bec o m es a ware of a S A E occ urri n g at a n y ti me after c o m pleti o n of t he 
st u d y a n d s/ he c o nsi ders t he S A E t o be relate d t o ceftazi di me-a vi bacta m , t he S A E als o m ust 
be re p ort e d t o Pfizer Saf et y.  
C a us alit y assess m e nt  
T he i n vesti gat or is re q uir e d t o assess a n d rec or d t h e ca usal relati o ns hi p. F or all A Es, 
s ufficie nt i nf or mati on s h o ul d be o btai ne d b y t he i n vesti gat or t o deter mi ne t he ca usalit y of 
eac h n o n-s eri o us A E. F or A Es wit h a ca us al relati o ns hi p t o ceftazi di me-a vi bacta m , f oll o w- u p 
b y t he i n vesti gat or is re q uire d u ntil t he e ve nt a n d/ or its se q uelae res ol ve or sta bilize at a le vel 
acce pta ble t o t he i n vesti g at or, a n d Pfizer c o nc urs wit h t hat assess me nt.  
A n i n vesti gat or’s ca us alit y assess me nt is t he deter mi nati o n of w het her t here e xists a 
reas o na bl e p ossi bilit y t hat ceftazi di me-a vi bact a m  ca use d or c o ntri b ute d t o a n A E. If t he 
i n vesti gat or’s fi nal deter mi nati o n of ca usalit y is “ u n k n o w n” a n d s/ he ca n n ot deter mi ne 
w het her ceftazi di me-a vi b acta m  ca use d t he e v e nt, t he safet y e ve nt m ust be re p orte d wit hi n 2 4 
h o urs. 
If t he i n vesti gat or ca n n ot deter mi ne t he eti ol o g y of t he e ve nt b ut s/ he det er mi nes t hat 
ceftazi di me-a vi bacta m  di d n ot ca use t he e v e nt, t his s h o ul d be clearl y d oc u me nte d o n t he 
C R F  a n d t he NI S A E M Re p ort F or m. 
D E FI NI TI O N S O F S A F E T Y E V E N T S  
A d verse e v e nts  
A n A E is a n y u nt o war d me dical occ urre n ce i n a patie nt a d mi nistere d a m e dici nal  pr o d uct. 
T he e ve nt nee d n ot necessaril y ha ve a ca usal relati o ns hi p wit h t he pr o d uct treat me nt or 
usa ge.  E xa m ples of A Es  i ncl u de b ut are n ot li mite d t o: 
•  A b n or mal test fi n di n gs (see bel o w f or circ u msta nces i n w hic h a n a b n or mal test 
fi n di n g c o nstit utes a n A E); 
•  Cli nicall y si g nifica nt si g ns a n d s y m pt o ms; 
•  C ha n ges i n p h ysical e xa mi nati o n fi n di n gs; 
•  H y perse nsiti vit y ; 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 6  of 5 7  
•  Pr o gressi o n/ w orse ni n g of u n derl yi n g disease; 
•  Lac k of efficac y ; 
•  Dr u g a b use; 
•  Dr u g de pe n d e nc y. 
A d diti o nall y, f or me dici nal pr o d ucts, t he y ma y i ncl u de t he si g ns or s y m pt o ms res ulti n g fr o m: 
•  Dr u g o ver d os e; 
•  Dr u g wit h dra w al; 
•  Dr u g mis use; 
•  Off -la b el use; 
•  Dr u g i nteracti o ns; 
•  E xtra vasati o n ; 
•  E x p os ure d uri n g p r e g na n c y; 
•  E x p os ure d uri n g br east f ee di n g; 
•  Me dicati o n err or; 
•  Occ u pati o nal e x p os ure.  
A b n or mal test fi n di n gs 
T he criteri a f or d eter mi ni n g w het her a n a b n or mal o bjecti ve test fi n di n g s h o ul d be re p orte d as 
a n A E  ar e as f oll o ws:  
•  Test res ult is ass ociate d wit h acc o m pa n yi n g s y m pt o ms, a n d/ or 
•  Test res ult re q uir es a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter v e nti o n, 
a n d/ or 
•  Test res ult lea ds t o a c h a n ge i n st u d y d osi n g or disc o nti n uati o n fr o m t he st u d y, 
si g nifica nt a d diti o nal c o nc o mita nt dr u g treat me nt, or ot her t hera p y, a n d/ or 
•  Tes t res ult is c o nsi dere d t o be a n A E  b y t he i n vesti gat or or s p o ns or. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 7  of 5 7  
Merel y re p eati n g a n a b n or mal test, i n t he a bse nce of a n y of t he a b o ve c o n diti o ns, d oes n ot 
c o nstit ute a n A E. A n y a b n or mal test res ult t hat is deter mi ne d t o be a n err or d oes n ot re q uire 
re p orti n g as a n A E. 
Seri o us a d verse e ve nts  
A S A E is a n y u nt o war d me dical occ urre n ce i n a patie nt a d mi nistere d a m e dici nal or 
n utriti o nal pr o d uct (i ncl u di n g pe diatric f or m ulas) at a n y d ose t hat: 
•  Res ults i n deat h; 
•  Is life-t hreate ni n g; 
•  Re q uires i n patie nt h os pitalizati o n or pr ol o n gati o n of h os pitalizati o n (see b el o w f or 
circ u msta nces t hat d o n ot c o nstit ute A Es); 
•  Res ults i n persiste nt or si g nifica nt disa bilit y/i nca pacit y  (s u bsta ntial disr u pti o n of t he 
a bilit y t o c o n d uct n or mal life f u ncti o ns); 
•  Res ults i n c o n ge nital a n o mal y/ birt h defect. 
Me dical a n d sci e ntific j u d g me nt is e xercise d i n deter mi ni n g w het her a n e ve nt is a n i m p orta nt 
me dical e ve nt. A n i m p ort a nt me dical e ve nt ma y n ot be i m me diatel y life -t hreate ni n g a n d/ or 
res ult i n deat h or h os pitalizati o n. H o we ver, if it is deter mi ne d t hat t he e v e nt ma y je o par dize 
t he patie nt or ma y r e q uir e i nter ve nti o n t o pre v e nt o ne of t he ot her o ut c o mes liste d i n t he 
defi niti o n a b o ve, t he i m p orta nt me dical e v e nt s h o ul d be re p orte d as seri o us. 
E xa m ples of s uc h e v e nts are i nte ns i ve treat me nt i n a n e mer g e nc y r o o m or at h o me f or 
aller gic br o n c h os pas m; bl o o d d yscrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n; 
or de vel o p me nt of dr u g d e pe n de n c y or dr u g a b use. 
A d diti o nall y, a n y s us pecte d tra ns missi o n via a Pfizer pr o d u ct of a n i nfecti o us a ge nt, 
pat h o ge nic or n o n- p at h o ge nic, is c o nsi dere d s eri o us. T he e ve nt ma y b e s us pecte d fr o m 
cli nical s y m pt o ms or la b orat or y fi n di n gs i n dicati n g a n i nfecti o n i n a patie nt e x p ose d t o a 
Pfizer pr o d uct. T h e ter ms “s us pecte d tra ns missi o n” a n d “t ra ns missi o n” are c o nsi dere d 
s y n o n y m o us. T hese cas es are c o nsi dere d u n e x pecte d a n d ha n dle d as seri o us e x pe dite d cas es 
b y p har mac o vi gila nce ( P V) pers o n n el. S uc h cases are als o c o nsi dere d f or re p orti n g as 
pr o d uct def ects, if a p pr o priate. 
H os pitalizati o n  
H os pitalizati o n is defi ne d as a n y i nitial a d missi o n (e ve n if less t ha n 2 4 h o urs) t o a h os pital or 
e q ui vale nt healt hcare facilit y or a n y pr ol o n gati o n t o a n e xisti n g a d missi o n. A d missi o n als o 
i ncl u des tra nsfer wit hi n t he h os pital t o a n ac ute/i nte nsi ve care u nit (e. g., fr o m t he ps yc hiatric 
wi n g t o a me dical fl o or, me dical fl o or t o a c or o nar y care u nit, ne ur ol o gical fl o or t o a 
t u berc ul osis u nit). A n e m er ge nc y r o o m visit d oes n ot necessaril y c o nstit ute a h os pitalizati o n; 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 8  of 5 7  
h o we ver, a n e ve nt lea di n g t o a n e mer ge n c y r o o m visit s h o ul d be assesse d f or me dical 
i m p orta nce.  
H os pitalizati o n i n t he a bse nce of a me dical A E is n ot i n itself a n A E a n d is n ot re p orta ble. 
F or e x a m ple, t he f oll o wi n g re p orts of h os pitalizati o n wit h o ut a me dical A E are n ot t o be 
re p orte d. 
•  S ocial a d miss i o n (e. g., patie nt has n o place t o slee p) 
•  A d mi nistrati ve a d missi o n (e. g., f or y earl y e xa m) 
•  O pti o nal a d missi o n n ot ass ociate d wit h a preci pitati n g me dical A E (e. g., f or electi ve 
c os metic s ur ger y)  
•  H os pitalizati o n f or o bser vati o n wit h o ut a me dical A E 
•  A d missi o n f or treat me nt of a pre -e xisti n g c o n diti o n n ot ass ociate d wit h t he 
de vel o p me nt of a n e w A E or wit h a w orse ni n g of t he pre-e xisti n g c o n diti o n (e. g., f or 
w or k - u p of p ersiste nt pre-treat me nt la b a b n or malit y) 
•  Pr ot oc ol-s pecifie d a d missi o n d uri n g cli nical st u d y (e. g., f or a pr oce d ure re q uire d b y 
t he st u d y pr ot oc ol) 
Sce n ari os  necessit ati n g re p orti n g t o Pfizer S afet y wit hi n 2 4 h o urs  
Sce nari os i n v ol vi n g e x p os ure d uri n g pre g n a nc y, e x p os ure d uri n g breastfee di n g, me dicati o n 
err or, o v er d ose, mis use, e xtra vas ati o n , lac k of effi cac y, a n d occ u p ati o nal e x p os ure are 
descri be d b el o w.  
E x p os ure d uri n g pr e g na n c y 
A n e x p os ure d uri n g pre g na nc y ( E D P) o cc urs if: 
1.  A fe male b ec o mes, or is f o u n d t o be, pre g n a nt eit her w hile recei vi n g or h a vi n g bee n 
e x p ose d t o (e. g., e n vir o n me ntal) ceftazi di me-a vi bacta m , or t he fe male b ec o mes, or is 
f o u n d t o be, pre g n a nt aft er disc o nti n ui n g a n d/or b ei n g e x p ose d c eftazi di me-a vi bacta m  
( mater nal e x p os ure). 
A n e xa m ple of e n vir o n m e ntal e x p os ure w o ul d be a case i n v ol vi n g direct c o ntact wit h a 
Pfizer pr o d uct i n a pre g n a nt w o ma n (e. g., a n urse re p orts t hat s he is pre g n a nt a n d has bee n 
e x p ose d t o c he m ot hera pe utic pr o d ucts). 
2.  A male has bee n e x p ose d, eit her d ue t o treat me nt or e n vir o n me ntal e x p os ure t o 
ceftazi di me-a vi bacta m  pri or t o or ar o u n d t he ti me of c o nce pti o n a n d/ or is e x p ose d d uri n g 
t he part ner pre g na n c y ( p ater nal e x p os ure) . 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 3 9  of 5 7  
As a ge neral r ule, pr os pecti ve a n d retr os pecti ve e x p os ure d uri n g pre g n a nc y re p orts fr o m a n y 
s o urce are r e p orta ble irres pecti ve of t he prese n ce of a n ass ociat e d A E a n d t he pr oce d ures f or 
S A E re p orti n g s h o ul d be f oll o we d. 
If a st u d y partici p a nt  or st u d y partici pa nt ’s part n er bec o mes, or is f o u n d t o be, pre g na nt 
d uri n g t he st u d y partici pa nt ’s treat me nt wit h ceftazi di me-a vi bact a m , t his i nf or mati o n m ust be 
s u b mitte d t o Pfizer, irres pecti ve of w h et her a n A E  has occ urre d  usi n g t he NI S A E M Re p ort 
F or m a n d t he E D P S u p ple me ntal F or m. 
I n a d diti o n, t he i nf or mati o n re gar di n g e n vir o n me ntal e x p os ure t o ceftazi di me-a vi bact a m  i n a 
pre g na nt w o ma n (e. g. , a patie nt re p orts t hat s he is pre g na nt a n d h as bee n e x p ose d t o a 
c yt ot o xic pr o d uct b y i n halati o n or s pilla ge) m ust be s u b mitte d usi n g t he NI S A E M Re p ort 
F or m a n d t he E D P S u p ple me ntal F or m. T his m ust be d o ne irres pecti ve of w het her a n A E has 
occ urr e d.  
I nf or mati o n s u b mitte d s h o ul d i ncl u de t he a ntici pat e d date of d eli ver y (s ee b el o w f or 
i nf or mati o n relate d t o ter mi nati o n of pre g na nc y). 
F oll o w- u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y; i n a d diti o n, 
f oll o w- u p is c o n d ucte d t o o btai n i nf or mati o n o n E D P o utc o me f or all E D P  re p orts wit h 
pre g na nc y o ut c o me u n k n o w n. A pre g n a nc y is f oll o we d u ntil c o m pleti o n or u ntil pre g na nc y 
ter mi nati o n (e. g., i n d uce d a b orti o n) a n d Pfizer is n otifie d of t he o utc o me. T his i nf or mati o n is 
pr o vi de d as a f oll o w-u p t o t he i nitial E D P  re p ort. I n t he case of a li ve birt h, t he str uct ural 
i nte grit y of t he ne o nate ca n be assess e d at t he ti me of birt h. I n t he e v e nt of a ter mi nati o n, t he 
reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grit y of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre - pr o ce d ur e test fi n di n gs are c o n cl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d). 
If t he o utc o me of t h e pre g na nc y meets t he criteria f or a n S A E (e. g., ect o pic pre g na nc y, 
s p o nta ne o us a b orti o n, i ntra uteri ne fetal de mise, n e o natal deat h, or c o n ge nit al a n o mal y [i n a 
li ve b or n, a ter mi nate d fet us, a n i ntra uteri ne fetal de mise, or a ne o n atal deat h]), t he 
pr oce d ur es f or re p orti n g S A Es  s h o ul d be f oll o we d. 
A d diti o nal i nf or mati o n a b o ut pre g na nc y o utc o m es t hat are re p orte d as S A Es f oll o ws: 
•  S p o nta ne o us a b orti o n i ncl u des miscarria g e a n d misse d a b orti o n; 
•  Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d 
t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs aft er 1  m o nt h s h o ul d be re p orte d as 
S A Es  w he n t he i n vesti gat or assesses t he i nfa nt deat h as relat e d or p ossi bl y relate d t o 
e x p os ure t o i n vesti gati o nal pr o d uct. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 0  of 5 7  
A d diti o nal i nf or mati o n re gar di n g t he e x p os ure d uri n g pre g na n c y ma y be re q ueste d. F urt h er 
f oll o w- u p of birt h o utc o mes will be ha n dle d o n a case- b y-cas e basis (e. g., f oll o w- u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela ys). 
I n t he cas e of pater nal e x p os ure, t he st u d y partici p a nt will be pr o vi de d  wit h t he Pre g na nt 
Part ner Releas e of I nf or m ati o n F or m t o deli ver t o his part ner.  It m ust be d oc u me nt e d t hat t he 
st u d y partici pa nt was gi v e n t his letter t o pr o vi de t o his part ner. 
E x p os ure d uri n g br eastfee di n g 
Sce nari os of e x p os ure d uri n g breastfee di n g m ust be re p ort e d, irres p ecti ve of t he prese n ce of 
a n ass ociate d A E. A n e x p os ure d uri n g breastfee di n g re p ort is n ot create d w he n a Pfizer dr u g 
s pecificall y a p pr o ve d f or use i n breastfee di n g w o me n (e. g., vita mi ns) is a d mi nistere d i n 
acc or d wit h a ut h orize d use. H o we v er, if t he i nfa nt e x perie n ces a n A E as s ociate d wit h s uc h a 
dr u g’s a d mi nistrati o n, t he A E is re p ort e d t o get her wit h t he e x p os ure d uri n g breastfee di n g. 
Me dicati o n err or  
A me dicati o n err or is a n y u ni nte nti o nal err or i n t he prescri bi n g, dis pe nsi n g, or a d mi nistrati o n 
of a me dici nal pr o d u ct t hat ma y ca use or lea d t o i n a p pr o priate m e dicati o n use or patie nt har m 
w hile i n t he c o ntr ol of t h e healt h care pr ofessi o nal, patie nt, or c o ns u mer. S uc h e ve nts ma y be 
relate d t o pr of essi o nal pr actice, h ealt h care pr o d u cts, pr oce d ures, a n d s yste ms i ncl u di n g: 
pres cri bi n g; or der c o m m u nicati o n; pr o d uct la beli n g, pac ka gi n g, a n d n o m e nclat ure; 
c o m p o u n di n g; dis pe nsi n g; distri b uti o n; a d mi nistrati o n; e d ucati o n; m o nit ori n g; a n d use. 
Me dicati o n err ors i ncl u d e:  
•  Near misses, i n v ol vi n g or n ot i n v ol vi n g a patie nt directl y (e. g., i na d v erte nt/err o ne o us 
a d mi nistrati o n, w hic h is t he acci de ntal use of a pr o d uct o utsi de of la beli n g or 
prescri pti o n o n t he part of t he healt hcare pr o vi der or t he patie nt/c o ns u mer); 
•  C o nf usi o n wit h re gar d t o i n ve nte d na me (e. g., tra d e na me, bra n d na me). 
•  T he i n vesti gat or m ust s u b mit t he f oll o wi n g me dicati o n err ors t o Pfizer, irres pecti ve of 
t he prese n ce of a n ass oci ate d A E/ S A E 
•  Me dicati o n err ors i n v ol vi n g patie nt e x p os ure t o t h e pr o d uct, w h et her or n ot t he 
me dicati o n err or is acc o m pa nie d b y a n A E . 
•  Me dicati o n er r ors t hat d o n ot i n v ol ve a patie nt directl y (e. g., p ote ntial me di cati o n 
err ors or near misses ). W he n a me dicati o n err or d oes n ot i n v ol ve patie nt e x p os ure t o 
t he pr o d uct t he f oll o wi n g mi ni m u m criteria c o nstit ute a me dicati o n err or re p ort: 
•  A n i de ntifia ble re p orter ; 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 1  of 5 7  
•  A s us pect pr o d uct; 
•  T he e ve nt me dicati o n err or. 
O ver d ose, Mis use, E xtr a vasati o n 
Re p orts of o ver d ose, mis use, a n d e xtra vasati o n ass ociate d wit h t he use of a Pfizer pr o d uct are 
re p orte d t o Pfizer b y t he i n vesti gat or, irres pecti ve of t he prese n ce of a n ass ociate d A E/ S A E . 
Lac k of Efficac y  
Re p orts of lac k of efficac y t o a Pfizer pr o d u ct are re p orte d t o Pfizer b y t h e i n vesti gat or, 
irres pecti ve of t he pr ese n ce of a n ass ociate d A E/ S A E or t he i n dicati o n f or use of t he Pfizer 
pr o d uct. 
Occ u pati o nal E x p os ur e 
Re p orts of occ u p ati o nal e x p os ure t o a Pfizer pr o d uct are re p orte d t o Pfizer b y t he 
i n vesti gat or, irres pecti ve of t he prese n ce of a n ass ociate d A E/ S A E. 
1 1. 2.  S afet y re p orti n g f or sec o n d ar y d at a c ollecti o n str uct ure d d at a a n al ysis  
Str uct ure d data fr o m site me dical rec or ds will be s ec o n dar y d ata c ollecti o n. T he str uct ure d 
data d o n ot c o ntai n i n di vi d ual-le vel ver bati m data. Re p orti n g re q uire me nt of safet y e v e nt f or 
str uct ure d data i n site me dical rec or ds will f oll o w t he i nstr ucti o ns bel o w. 
T his st u d y i n v ol ves data t hat e xist as str uct ure d data b y t he ti me of i n vesti gat or start i n p ut 
data fr o m me dical rec or d i nt o C R F.  
I n t hes e data s o urces, i n di vi d ual patie nt data are n ot retrie ve d or v ali date d, a n d it is n ot 
p ossi ble t o li n k (i.e., i de ntif y a p ote ntia l ass ociati o n bet wee n) a partic ular pr o d uct a n d 
me dical e ve nt f or a n y i n di vi d ual.  T h us, t he mi ni m u m criteria f or re p orti n g a n a d vers e e v e nt 
( A E) (i.e., i d e ntifia ble patie nt, i de ntifia ble re p orter, a s us pect pr o d u ct, a n d e ve nt) ca n n ot be 
met.  
1 1. 3.  S afet y re p ort i n g f or sec o n d ar y d at a c ollecti o n re q uires  h u m a n re vie w of 
u nstr uct ure d d at a  
U nstr uct ure d D ata fr o m site me dical rec or ds will be re vie w e d b y i n vesti gat ors. Re p orti n g 
re q uire me nt of s afet y e ve nt w he n re vie wi n g u nstr uct ure d data i n site me dical rec or ds will 
f oll o w t he i nstr ucti o ns bel o w. 
R E Q UI R E M E N T S  
T his st u d y pr ot oc ol re q uires h u ma n re vi e w of p atie nt-le vel u nstr uct ure d dat a; u nstr uct ure d 
data refer t o ver bati m me dical data, i ncl u di n g te xt- base d descri pti o ns a n d vis ual de picti o ns of 
me dical i nf or mati o n, s uc h as me dical rec or ds, i ma ges of p h ysicia n n otes, n e ur ol o gical sca ns, 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 2  of 5 7  
X- ra ys, or n arr ati ve fiel ds i n a data base.  T h e re vie wer is o bli gate d t o re p ort a d verse e ve nts 
( A Es) wit h e x plicit attri b uti o n t o a n y Pfizer dr u g t hat a p pear i n t he re vie we d i nf or mati o n 
( defi ne d p er t he patie nt p o p ulati o n a n d st u d y peri o d s pecifie d i n t he pr ot oc ol).  E x plicit 
attri b uti o n is n ot i nferre d b y a te m p oral relati o ns hi p bet wee n dr u g a d mi nistrati o n a n d a n A E, 
b ut m ust be base d o n a d efi nite state me nt of ca usalit y b y a healt hcare pr o vi der li n ki n g dr u g 
a d mi nistrati o n t o t he A E.  
T he re q uir e me nts f or r e p orti n g safet y e ve nts o n t h e n o n-i nter ve nti o nal st u d y ( NI S) A E M 
Re p ort F or m t o Pfizer Safet y ar e as f oll o ws:  
•  All seri o us a n d n o n- seri o us A Es wit h e x plicit attri b uti o n t o a n y Pfizer dr u g  t hat 
a p pear i n t he re vie we d i nf or mati o n m ust be rec or d e d o n t he C R F  a n d re p ort e d, wit hi n 
2 4 h o urs of a w are n ess, t o Pfizer Safet y usi n g t he NI S A E M Re p ort F or m. 
•  Sce nari os i n v ol vi n g dr u g e x p os ure, i ncl u di n g e x p os ure d uri n g pre g n a nc y, e x p os ure 
d uri n g breast f ee di n g, me dicati o n err or, o v er d ose, mis use, e xtra vasati o n, lac k of 
efficac y, a n d o cc u p ati o nal e x p os ure ass ociate d wit h t he use of a Pfizer pr o d uct m ust 
be re p ort e d, wit hi n 2 4 h o urs of a w are n ess, t o Pfizer Safet y usi n g t he NI S A E M 
Re p ort F or m. 
F or t hese A Es wit h a n e x plicit attri b uti o n or sce nari os i n v ol vi n g e x p os ure t o a Pfizer pr o d uct, 
t he safet y i nf or m ati o n i de ntifie d i n t he u nstr uct ure d data re vie we d is ca pt ure d i n t he E ve nt 
Narr ati ve secti o n of t he r e p ort f or m, a n d c o nstit utes all cli nical i nf or mati o n k n o w n re gar di n g 
t hese A Es.  N o f oll o w- u p o n relate d A Es will be c o n d ucte d. 
All resear c h staff me m bers m ust c o m plete t he f oll o wi n g Pfizer trai ni n g re q uire me nts:    
•   “ Y o ur Re p orti n g Res p o nsi bilities ( Y R R) Tr ai ni n g f or Ve n d ors ” .  
T hese trai ni n gs m ust b e c o m plete d b y researc h staff me m bers  pri or t o t he start of data 
c ollecti o n.  All trai ni n gs i ncl u de a “ C o nfir mati o n of Trai ni n g Certificate” (f or si g nat ure b y 
t he trai nee) as a rec or d of c o m pleti o n of t he trai ni n g, w hic h m ust be ke pt i n a retrie v a ble 
f or mat.  C o pies of all si g ne d trai ni n g certificates m ust be pr o vi de d t o Pfizer.  
Re -trai ni n g m ust be c o m plete d o n a n a n n u al basis usi n g t he m ost c urre nt Y o ur Re p orti n g 
Res p o nsi bilities trai ni n g materials.  
1 1. 4.  Si n gle refere nce s afet y d oc u me nt  
T he pr o d uct la b el of Za vi cefta ® ( ceftazi di me-a vi bacta m ) a p pr o ve d i n C hi na will ser ve as t he 
si n gle refere nce saf et y d oc u me nt d uri n g t he c o urs e of t he st u d y, w hic h will be use d b y Pfizer 
safet y t o assess a n y s afet y e ve nts re p ort e d t o Pfizer Safet y b y t he i n vesti gat or d uri n g t he 
c o urse of t his st u d y. 
T he si n gle ref ere n ce s afet y d oc u me nt  s h o ul d be use d b y t he i n vesti gat or f or prescri bi n g 
p ur p oses a n d g ui da n ce. 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 3  of 5 7  
1 2.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e. g., cli nical h ol d) b y a n a p plica ble 
c o m pete nt aut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n w hic h mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of a Pfizer 
pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y. 
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur g e nt safet y meas ures 
ta ke n b y t he i n vesti gat or t o pr otect t he st u d y patie nts a gai nst a n y i m me diate hazar d, a n d of 
a n y seri o us breac h es of t his n o n-i nter ve nti o nal st u d y pr ot oc ol t hat t h e i n vesti gat or bec o mes 
a war e of.  
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 4  of 5 7  
1 3.  R E F E R E N C E S  
 
1. 
C hi na A nti micr o bial Resista nce S ur veilla nce S yste m. A nti micr o bial resista nce of 
bacteria: s ur v eilla nce re p ort fr o m C hi na A nti micr o bial Resista nce S ur veilla nce 
S yste m i n 2 0 1 4- 2 0 1 9. C hi n J I nfect C o ntr ol. 2 0 2 1; 2 0( 1): 1 5- 3 1. 
2.  
C hi na A nti micr o bial S ur veilla nce N et w or k. ( 2 0 2 0).  Distri b uti o n of maj or strai ns 
fr o m t he 2 5 1 1 3 5 is olates fr o m h os pital. A vaila ble fr o m: 
htt p:// w w w.c hi nets.c o m/ Data/ A nti bi otic Dr u g Fast. Access e d o n: 2 J ul y 2 0 2 1. 
3.  
Li u J, Z ha n g L, Pa n J, et al. Ris k Fact ors a n d M ol ec ular E pi d e mi ol o g y of 
C o m plicate d I ntr a - A b d o mi nal I nfecti o ns Wit h Car ba pe ne m-Resista nt 
E nter o bact eriaceae: A M ultice nter St u d y i n C hi na. J I nfect Dis. 2 0 2 0; 2 2 1( S u p pl 
2): S 1 5 6- S 6 3. 
4.  
W u A, We n X, Li C, et al. C hi na nati o nal p oi nt pre vale nce s ur ve y o n h ealt hcare-
ass ociate d i nfecti o n a n d a nti micr o bial use i n 2 0 1 2. C hi nese J o ur nal of I nfecti o n 
C o ntr ol. 2 0 1 4; 1 3: 8- 1 5. 
5.  
Re n N, We n X, W u A. St u d y o n t he c ha n gi n g tre n ds i n nati o nal n os oc o mial i nfecti o n 
tra nsecti o n i n vesti gati o n res ults. C hi nese J o ur nal of I nfecti o n C o ntr ol. 2 0 0 7; 6: 1 6- 8. 
6. 
Fis h D N, Piscitelli S C, Da nzi ger L H. De v el o p me nt of resista nce d uri n g a nti micr o bial 
t hera p y: a r e vie w of a nti bi otic classes a n d patie nt c haracteristics i n 1 7 3 st u dies. 
P har mac ot her a p y. 1 9 9 5; 1 5( 3): 2 7 9- 9 1. 
7. 
Sa nc hez G arci a M. Earl y a nti bi otic treat me nt fail ure. I nt J A nti micr o b A ge nts. 
2 0 0 9; 3 4 S u p pl 3: S 1 4- 9. 
8.  
Gis ke C G, M o n net D L, Cars O, et al. Cli nical a n d ec o n o mic i m pact of c o m m o n 
m ulti dr u g -resista nt gra m-ne gati ve bacilli. A nti micr o b A ge nts C he m ot her. 
2 0 0 8; 5 2( 3): 8 1 3- 2 1. 
9.  
Ne u ha user M M, Wei nstei n R A, R y d ma n R, et al. A nti bi otic resista nce a m o n g gra m-
ne gati ve bacilli i n U S i nte nsi ve care u nits: i m plicati o ns f or fl u or o q ui n ol o ne use. 
J A M A. 2 0 0 3; 2 8 9( 7): 8 8 5- 8. 
1 0.  
Paters o n D L, B o n o m o R A. E x te n de d-s p ectr u m beta-lacta mas es: a cli nical u p date. 
Cli n Micr o bi ol Re v. 2 0 0 5; 1 8( 4): 6 5 7- 8 6. 
1 1.  
Perez F, H ujer A M, H ujer K M, et al. Gl o bal c h alle n ge of m ulti dr u g- resista nt 
Aci net o bact er ba u ma n nii. A nti micr o b A ge nts C he m ot her. 2 0 0 7; 5 1( 1 0): 3 4 7 1- 8 4. 
1 2. 
Perez F, El C ha k ht o ura N G, Pa p p- Wallace K M, et al. Treat me nt o pti o ns f or 
i nfecti o ns ca use d b y car b a pe ne m-resista nt E nter o b acteriaceae: ca n we a p pl y 
" precisi o n me dici ne" t o a nti micr o bial c he m ot hera p y? E x pert O pi n P har mac ot her. 
2 0 1 6; 1 7( 6): 7 6 1- 8 1. 
1 3.  
W o n g D, va n D ui n D. N o vel Beta- Lacta mase I n hi bit ors: U nl oc ki n g T heir P ote ntial i n 
T hera p y. Dr u gs. 2 0 1 7; 7 7( 6): 6 1 5- 2 8. 
1 4. 
Za viceft a (ceftazi di me -a vi bacta m). L L D a vi bacta m s o di u m ceftazi di me pe nta h y drate 
- Za vicefta - C H N - Si m plifie d ( C H N); 1 7 A u g ust 2 0 2 0, O perati o ns S u p p ort Gr o u p, 
Ri n gas ki d d y, C o u nt y C or k, Irela n d: Pfizer Irela n d P har mace uticals. A vaila ble fr o m: 
htt p://la beli n g. pfizer.c o m/ S h o w La beli n g.as p x?i d = 1 4 4 7 3. Access e d o n: 2 5 Ma y 2 0 2 1. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 5  of 5 7  
1 5.  
L ucasti C, P o pesc u I, Ra mes h M K, et al. C o m parati ve st u d y of t he efficac y a n d safet y 
of ceft azi di me/a vi bact a m pl us metr o ni daz ole vers us mer o pe ne m i n t he treat me nt of 
c o m plicate d i ntra- a b d o mi nal i nfecti o ns i n h os pitalize d a d ults: res ults of a 
ra n d o mize d, d o u ble- bli n d, P hase II trial. J A nti micr o b C he m ot her. 2 0 1 3; 6 8( 5): 1 1 8 3-
9 2. 
1 6. 
Vaz q uez J A, G o n zalez Patza n L D, Stric kli n D, et al. Efficac y a n d s afet y of 
ceftazi di me-a vi bacta m v ers us i mi pe ne m -cilastati n i n t he treat me nt of c o m plicate d 
uri nar y tract i nfecti o ns, i ncl u di n g ac ute p yel o n e p hritis, i n h os pitalize d a d ults: res ults 
of a pr os pecti ve, i n vesti gat or- bli n de d, ra n d o mize d st u d y. C urr Me d Res O pi n. 
2 0 1 2; 2 8( 1 2): 1 9 2 1- 3 1. 
1 7.  
Maz us ki J E, Gasi n k L B, Ar mstr o n g J, et al. Efficac y a n d Safet y of Ceftazi di me-
A vi bacta m Pl us Metr o ni daz ole V ers us Mer o p e ne m i n t he Treat me nt of C o m plicate d 
I ntr a-a b d o mi nal I nfecti o n: Res ults Fr o m a Ra n d o mize d, C o ntr olle d, D o u ble- Bli n d, 
P hase 3 Pr o gra m. Cli n I nfect Dis. 2 0 1 6; 6 2( 1 1): 1 3 8 0- 8 9. 
1 8.  
T orres A, Z h o n g N, Pac hl J, et al. Ceftazi di me-a vi bacta m vers us mer o pe n e m i n 
n os oc o mial p ne u m o nia, i ncl u di n g ve ntilat or -ass ociate d p ne u m o nia ( R E P R O V E): a 
ra n d o mise d, d o u ble- bli n d, p hase 3 n o n-i nferi orit y trial. La ncet I nfect Dis. 
2 0 1 8; 1 8( 3): 2 8 5- 9 5. 
1 9. 
K na us W A, Dra per E A, Wa g ner D P, et al. A P A C H E II: a se v erit y of disease 
classificati o n s yste m. Crit Care Me d. 1 9 8 5; 1 3( 1 0): 8 1 8- 2 9. 
2 0. 
Frie d ma n N D, Ka y e K S, St o ut J E, et al. Healt h care --ass o ciate d bl o o dstrea m 
i nfecti o ns i n a d ults: a reas o n t o c ha n ge t he acce pte d defi niti o n of c o m m u nit y-
ac q uire d i nf ecti o ns. A n n I nter n Me d. 2 0 0 2; 1 3 7( 1 0): 7 9 1- 7. 
2 1.  
Car d os o T, Ri beir o O , Ar a ga o I, et al. T he i m pact of healt hcare-ass ociate d i nfecti o n 
o n m ortalit y: fail ure i n cli nical rec o g niti o n is relat e d wit h i na de q uate a nti bi otic 
t hera p y. P L o S O ne. 2 0 1 3; 8( 3):e 5 8 4 1 8. 
2 2.  
C h o w A W, E va ns G A, N at he ns A B, et al. Ca na dia n practice g ui d eli nes f or s ur gical 
i ntra-a b d o mi nal i nfecti o ns. Ca n J I nfect Dis Me d Micr o bi ol. 2 0 1 0; 2 1( 1): 1 1- 3 7. 
2 3.  
Ma gi ora k os A P, Sri ni vasa n A, Care y R B, et al. M ulti dr u g-resista nt, e xte nsi vel y dr u g-
resista nt a n d pa n dr u g-resista nt bacteria: a n i nter nati o nal e x pert pr o p osal f or i nteri m 
sta n dar d defi niti o ns f or ac q uire d resista nce. Cli n Micr o bi ol I nfect. 2 0 1 2; 1 8( 3): 2 6 8-
8 1. 
2 4.  
De y o R A, C her ki n D C, Ci ol M A. A da pti n g a cli nical c o m or bi dit y i n de x f or use wit h 
I C D- 9- C M a d mi nistrati ve data bas es. J Cli n E pi de mi ol. 1 9 9 2; 4 5( 6): 6 1 3- 9. 
2 5. 
He n ders o n H, L uter bac h C L, C o ber E, et al. T he Pitt Bactere mia Sc ore Pre dicts 
M ortalit y i n N o n bactere mic I nfecti o ns. Cli n I nfect Dis. 2 0 2 0; 7 0( 9): 1 8 2 6- 3 3. 
 
2 6.   
C h o w A W, E va ns G A, N at he ns A B, et al. Ca na dia n practice g ui d eli nes f or s ur gical 
i ntra-a b d o mi nal i nfecti o ns. Ca n J I nfect Dis Me d Micr o bi ol. 2 0 1 0; 2 1( 1): 1 1- 3 7. 
2 7.  
Ma gi ora k os A P, Sri ni vasa n A, Care y R B, et al. M ulti dr u g-resista nt, e xte nsi vel y dr u g-
resista nt a n d pa n dr u g-resista nt bacteria: a n i nter nati o nal e x pert pr o p osal f or i nteri m 
stan dar d defi niti o ns f or ac q uire d resista nce. Cli n Micr o bi ol I nfect. 2 0 1 2; 1 8( 3): 2 6 8-
8 1. 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 6  of 5 7  
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  
N o ne. 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 7  of 5 7  
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  
N ot  a p plica ble.  
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 8  of 5 7  
A N N E X 3. C RI T E RI A F O R E V A L U A TI O N O F C LI NI C A L A N D 
MI C R O BI O L O GI C A L O U T C O M E  
E v al u ati o n  
O utc o m e  
S u b c ate g or y 
Criteri a  
Cli nical 
E val uati o n  
S uccess  
C ure  
Res ol uti o n of all si g ns a n d s y m pt o ms of 
i nfecti o n s uc h t hat n o f urt her a nti micr o bial 
t hera p y is necessar y. 
 
Disc o nti n uati o n  of t he a nti bi otic t hera p y is 
c o nsi dere d a treat me nt s uccess.  
Fail ure  
Fail ure  
I na de q uate res p o nse t o ceftazi di me -
a vi bacta m t hera p y or resista nt, w orse ni n g, or 
ne w rec urre nt si g ns a n d s y m pt o ms at t he e n d 
of ceftazi di me -a vi bacta m t hera p y. 
 
T his ma y i ncl u de t he a d diti o n of ot her   
a nti bi otic t hera p ies(e xce pt bacteria or 
car ba pe na mases   t hat are o utsi de t he 
treat me nt s pectr u m of ceftazi di me-a vi bacta m ) 
after 4 da ys of treat me nt,  disc o nti n uati o n of 
ceftazi di me -a vi bacta m wit h o ut cli nical c ure 
(e. g., A E, i ns ufficie nt effect), or rea d missi o n 
t o a h os pital wit h sa me i nfecti o n wit hi n 6 0 
da ys of t he i nitial h os pital  disc har ge date.  
I n deter mi nate 
I n deter mi nate 
T here is n ot e n o u g h i nf or mati o n t o c o ncl u de 
w het her t he a nti bi otic re gi me n c o ntai ni n g 
ceftazi di me -a vi bacta m was a cli nical fail ure 
or a s uccess.  
Micr o bi ol o gical 
E val uati o n  
S uccess  
Era dicati o n  
A bse nce of ca usati ve pat h o ge n fr o m 
a p pr o priatel y o btai ne d s peci me ns at t he site 
of i nfecti o n.  
Pres u me d 
Era dicati o n  
Re peat c ult ures were n ot perf or me d/cli nicall y 
i n dicate d i n a patie nt w h o ha d a cli nical 
res p o nse of c ure. 
C ol o nizati o n  
Detecti o n of pat h o ge n fr o m t he site of 
i nfecti o n d uri n g t hera p y wit h o ut nee d f or 
a nti micr o bial treat me nt or a s u peri nfecti o n 
wit h a micr o bi ol o gical a ge nt o utsi de t he 
treat me nt s pectr u m of ceftazi di me -a vi bacta m 
( G +/f u n gi). 
Fail ure  
N ot Era dicate d  
Detecti o n of pat h o ge n  fr o m t he site of 
i nfecti o n after c o m pleti o n of t hera p y. 
P res u me d N ot 
Era dicate d  
A bse nce of a p pr o priate material f or c ult ure or 
a bse nce of res ults of c o ntr ol micr o bi ol o gical 
tests c o u ple d wit h lac k of cli nical 
i m pr o ve me nt after a pat h o ge n was i nitiall y 
is olate d. 
E mer ge nt 
I nfecti o ns 
S u peri nfecti o n  
Detecti o n of a ne w pat h o ge n fr o m t he site of 
i nfecti o n d uri n g t hera p y wit h nee d f or 
a d diti o nal a nti micr o bial treat me nt. 
Ne w I nfecti o n  
Detecti o n of a ne w pat h o ge n fr o m t he site of 
i nfecti o n after t hera p y wit h nee d f or 
a d diti o nal a nti micr o bial treat me nt. 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 4 9  of 5 7  
E v al u ati o n  
O utc o m e  
S u b c ate g or y 
Criteri a  
U ne val ua ble  
U ne val ua ble  
Patie nts wit h o ut c ult ures or e vi de nt pat h o ge ns 
fr o m t he pres u me d site of i nfecti o n. 
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 0  of 5 7  
A N N E X 4. D E Y O -C H A R L S O N C O M O R BI DI T Y I N D E X  
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)
C O P Y RI G H T E D M A T E RI A L

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 1  of 5 7  
A N N E X 5. A P A C H E II  
T otal A P A C H E II Sc ore = s u m of ( A. T otal A c ute P h ysi ol o g y Sc ore (A P S) , B. A ge, a n d C. 
C hr o nic Healt h Sc ore). 
A.  A P A C H E II Sc ore F or m  
P H Y SI O L O GI C 
V A RI A B L E  
HI G H A B N O R M A L R A N G E                                        L O W A B N O R M A L R A N G E  
+ 4  
+ 3  
+ 2  
+ 1  
0  
+ 1  
+ 2  
+ 3  
+ 4  
1.  Te m perat ure –  rectal 
(° C) 
≥4 1  
3 9 -4 0. 9  
 
3 8. 5 -3 8. 9  
3 6 -3 8. 4  
3 4 -3 5. 9  
3 2 -3 3. 9  
3 0 -3 1. 9  
≤2 9. 9  
2.  Mea n arterial press ure 
( m m H g) 
≥1 6 0  
1 3 0 -1 5 9  1 1 0 -1 2 9  
 
7 0 -1 0 9  
 
5 0 -6 9  
 
≤4 9  
3.  Heart rate ( ve ntric ular 
res p o nse) 
≥1 8 0  
1 4 0 -1 7 9  1 1 0 -1 3 9  
 
7 0 -1 0 9  
 
5 5 -6 9  
4 0 -5 4  
≤3 9  
4.  Res pirat or y rate ( n o n -
v e ntilate d or ve ntilate d)  
≥5 0  
3 5 -4 9  
 
2 5 -3 4  
1 2 -2 4  
1 0 -1 1  
6 -9  
 
≤5  
5.  O x y ge nati o n  
A- a D O 2 or Pa O 2 
( m m H g) 
 
 
 
 
 
 
 
 
 
    a) Fi O 2 ≥0. 5:  rec or d 
A -a D O 2 
≥5 0 0  
3 5 0 -4 9 9  2 0 0 -3 4 9  
 
< 2 0 0  
 
 
 
 
    b) Fi O 2 < 0. 5:  rec or d o nl y 
Pa O 2 
 
 
 
 
> 7 0  
6 1 -7 0  
 
5 5 -6 0  
< 5 5  
6.  Arterial p H - If n o 
A B Gs rec or d Ser u m use 
H C O 3 bel o w  
≥7. 7  
7 . 6-7. 6 9  
 
7 . 5-7. 5 9  
7 . 3 3-7. 4 9  
 
7 . 2 5-7. 3 2  
7 . 1 5-7. 2 4  
< 7. 1 5  
7.  Ser u m S o di u m 
( m m ol/ L) 
≥1 8 0  
1 6 0 -1 7 9  1 5 5 -1 5 9  
1 5 0 -1 5 4  
1 3 0 -1 4 9  
 
1 2 0 -1 2 9  
1 1 1 -1 1 9  
≤1 1 0  
8.  Ser u m P otassi u m 
( m m ol/ L) 
≥7  
6 -6. 9  
 
5 . 5-5. 9  
3 . 5-5. 4  
3 -3. 4  
2 . 5-2. 9  
 
< 2. 5  
9.  Ser u m Creati ni ne 
( m g/ d L) 
D o u ble p oi nt sc ore f or 
ac ute re nal fail ure 
≥3. 5  
2 -3. 4  
1 . 5-1. 9  
 
0 . 6-1. 4  
 
< 0. 6  
 
 
1 0. He mat ocrit ( %)  
≥6 0  
 
5 0 -5 9. 9  
4 6 -4 9. 9  
3 0 -4 5. 9  
 
2 0 -2 9. 9  
 
< 2 0  
1 1. W hite Bl o o d C o u nt 
(/ m m3) (i n 1. 0 0 0s) 
≥4 0  
 
2 0 -3 9. 9  
1 5 -1 9. 9  
3 -1 4. 9  
 
1 -2. 9  
 
< 1  
1 2. Glas g o w C o ma Scale 
( Sc ore = 1 5 mi n us 
act u al G C S) 
 
 
 
 
 
 
 
 
 
A. A P S  
S u m of t he 1 2 i n di vi d u al p oi nts =  
∗  Ser u m H C O 3 ( ve n o us-
m m ol/ L) (N ot preferre d, 
use if n o A B Gs ) 
≥5 2  
4 1 -5 1. 9  
 
3 2 -4 0. 9  
2 2 -3 1. 9  
 
1 8 -2 1. 9  
1 5 -1 7. 9  
< 1 5  
A b bre viati o ns: A -a D O 2 = al ve olar-arterial o x y ge n g ra die nt, Pa O 2 = p artial press ure of o x y ge n , Fi O 2 = 
fracti o n of i ns pire d o x y ge n, A B G = arterial bl o o d gas , H C O 3 = b icar b o nate, G C S  = Glas g o w C o ma Scale  
 
B.  A ge Sc ore  
 
A G E  ( ye ars) 
Sc ore  
≤ 4 4  
0  
4 5 –  5 4  
2  
5 5 –  6 4  
3  
6 5 –  7 4  
5  
≥ 7 5  
6  
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 2  of 5 7  
C.  C hr o nic He alt h Sc ore  
If a patie nt  h as a hist or y of se ver e or ga n s yste m i ns ufficie nc y or is i m m u n oc o m pr o mise d, 
assi g n p oi nts as f oll o ws: 
a. F or n o n o perati ve or e mer ge nc y p ost o perati ve patie nts — 5 p oi nts 
b.  F or electi ve p ost o per ati ve patie nts  — 2 p oi nts] 
 
Defi niti o ns  
Or ga n i ns uffici e nc y or i m m u n oc o m pr o mise d state m ust ha ve bee n e vi de nt pri or t o t his 
h os pital a d missi o n a n d c o nf or m t o t he f oll o wi n g criteria: 
LI V E R: Bi o ps y pr o ve n cirr h osis a n d d oc u me nte d p ortal h y perte nsi o n; e pis o des of past u p per 
gastr oi ntesti nal  blee di n g attri b ute d t o p ortal h y perte nsi o n; or pri or e pis o des of he patic 
fail ure/e n ce p hal o pat h y/c o ma. 
C A R DI O V A S C U L A R: Ne w Y or k Heart Ass ociati o n Class I V  —  Patie nts wit h car diac 
disease res ulti n g i n i na bilit y t o carr y o n a n y p h ysical acti vit y wit h o ut disc o mf ort. S y m pt o ms 
of heart f ail ure or t h e a n gi nal s y n dr o me ma y be prese nt e ve n at rest. If a n y p h ysical acti vit y 
is u n derta ke n, disc o mf ort i ncreas es. 
R E S PI R A T O R Y: C hr o nic restricti ve, o bstr u cti ve, or vasc ular dis ease res ulti n g i n se vere 
e xercis e restricti o n, i.e., u na ble t o cli m b stairs or perf or m h o use h ol d d uties; or d oc u me nte d 
c hr o nic h y p o xia, h y perca p nia, sec o n dar y p ol yc yt h e mia, se vere p ul m o nar y h y perte nsi o n 
( > 4 0 m m H g), or r es pirat or de pe n de n c y. 
R E N A L: recei vi n g c hr o nic dial ysis. 
I M M U N O C O M P R O MI S E D: T he patie nt has recei ve d t herap y t h at s u p presses resista nce t o 
i nfecti o n, e. g., i m m u n os u p pressi o n, c he m ot hera p y, ra diati o n, l o n g ter m or rece nt hi g h d ose 
ster oi ds, or has a disease t hat is s ufficie ntl y a d va n ce d t o s u p press resista nce t o i nfecti o n, e. g., 
le u ke mia, l y m p h o ma, AI D S. 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 3  of 5 7  
A N N E X 6. S E Q U E N TI A L O R G A N F AI L U R E A S S E S S M E N T  ( S O F A) S C O R E *  
 
* Si n ger M, De utsc h ma n C S, Se y m o ur C W, et al:  T he t hir d i nter nati o nal c o nse ns us defi niti o ns f or se psis a n d 
se ptic s h oc k（se psis- 3）.J A M A 3 1 5: 8 0 1 -8 1 0, 2 0 1 6 . 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  
2 0 -Ma y -2 0 2 1  
Pa ge 5 4  of 5 7  
A N N E X 7. PI T T B A C T E R E MI A S C O R E  
T he Pitt bactere mia sc ore is wi del y use d i n i nfecti o us disease res earc h as a se verit y of ac ute 
ill ness i n de x. It r a n ges fr o m 0 t o 1 4 p oi nts, wit h a sc ore ≥4 c o m m o nl y use d as a n i n dicat or of 
critical ill ness a n d i ncrease d ris k of deat h . 4 0 
 
Pitt bactere mia sc or e ass essi n g se verit y of ill ness ( 1 9 9 8 versi o n) 
Fe ver ( or al)  
 
< = 3 5 ℃ 
2 p oi nts  
3 6 ℃ 
1 p oi nt  
3 6. 1 -3 8. 9 ℃ 
0 p oi nts  
3 9 ℃ 
1 p oi nt  
> = 4 0 ℃ 
2 p oi nts  
H y p ote nsi o n  
(a) Ac ute h y p ote nsi ve e v e nt dr o p i n 
s yst olic > 3 0 m m H g a n d diast olic > 2 0 
m m H g; or  
( b) Re q uire me nt f or i ntra v e n o us press or 
a ge nts; or 
(c) S yst olic bl o o d press ure < 9 0 m m H g 
 
2 p oi nts 
Mec ha nical ve ntilati o n  
2 p oi nts  
Car diac arrest  
4 p oi nts  
Me ntal stat us: alert  
0 p oi nt  
Dis orie nte d  
1 p oi nt  
St u p or o us  
2 p oi nts  
C o mat ose  
4 p oi nts  
* All para meters gra d e d wit hi n 2 da ys pri or t o or o n t he da y of first p ositi ve bl o o d c ult ure. 
Ta ke t he hi g hest sc ore d uri n g t hat ti me. 
Criticall y ill defi ne d as acc u m ulati o n of greater or e q ual t o 4 p oi nts fr o m t he a b o ve 
cate g ories.  
 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  2 0 -Ma y -2 0 2 1  
Pa ge 5 5  of 5 7  
A N N E X 8. D A T A A B S T R A C TI O N S C H E D U L E  
 
Ti me of visit  
Baseli ne  
(fr o m date of 
a d missi o n t o 
i n de x date or 
fr o m 7 da ys 
bef ore i n de x 
date t o i n de x 
date)  
I n de x date 
(Recei ve ≥1  
d ose of 
ceftazi di me -
a vi bacta m ) 
Da y 7, Da y 1 4, 
Da y 2 1, Da y 
3 0, Da y 6 0,  
a n d at E O T 
after i n de x date 
Disc har ge 
fr o m i n de x 
h os pitalizati o n  
Da y 3 0 a n d 
Da y 6 0 after 
disc har ge  
E n d of 
o bser vati o n  
Ce ntral la b 
eval uati o n  
I nf or me d c o nse nt 
 
 
 
 
 
 
 
De m o gra p hic 
c haracteristics ( A ge, 
Se x, E m pl o y me nt, 
Hei g ht, wei g ht, etc)  
 
 
 
 
 
 
 
Me dical hist or y 
( Alc o h ol 
c o ns u m pti o n, 
S m o ki n g, 
C o m or bi dit y, etc)  
 
 
 
 
 
 
 
A d missi o n 
dia g n osis  
 
 
 
 
 
 
 
Pre -treat me nt 
disease se verit y  
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  2 0 -Ma y -2 0 2 1  
Pa ge 5 6  of 5 7  
Ti me of visit  
Baseli ne  
(fr o m date of 
a d missi o n t o 
i n de x date or 
fr o m 7 da ys 
bef ore i n de x 
date t o i n de x 
date)  
I n de x date 
(Recei ve ≥1  
d ose of 
ceftazi di me -
a vi bacta m ) 
Da y 7, Da y 1 4, 
Da y 2 1, Da y 
3 0, Da y 6 0,  
a n d at E O T 
after i n de x date 
Disc har ge 
fr o m i n de x 
h os pitalizati o n  
Da y 3 0 a n d 
Da y 6 0 after 
disc har ge  
E n d of 
o bser vati o n  
Ce ntral la b 
eval uati o n  
S o urce of i nfecti o n  
 
 
 
 
 
 
 
C eftazi di me -
a vi bacta m  treat me nt 
i nf or mati o n (e. g., 
d osa ge, fre q ue nc y,  
etc.)   
 
 
 
 
 
 
 
I n dicati o n f or 
ceftazi di me -
a vi bacta m 
 
 
 
 
 
 
 
 Micr o bi ol o g y 
sa m ple after 
treat me nt i nitiati o n  
 
 
 
 
 
 
 
Micr o bi ol o g y 
res ults after 
treat me nt i nitiati o n 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)

Ceftazi di me -A vi bacta m  
C 3 5 9 1 0 3 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Pr ot oc ol A me n d me nt 3, 1 2 A pril  2 0 2 2   
 
 
P FI Z E R C O N FI D E N TI A L   
 C T 2 4 -WI -G L 0 2 -R F 0 1 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Pri m ary D at a C ollecti o n St u dy  2 0 -Ma y -2 0 2 1  
Pa ge 5 7  of 5 7  
Ti me of visit  
Baseli ne  
(fr o m date of 
a d missi o n t o 
i n de x date or 
fr o m 7 da ys 
bef ore i n de x 
date t o i n de x 
date)  
I n de x date 
(Recei ve ≥1  
d ose of 
ceftazi di me -
a vi bacta m ) 
Da y 7, Da y 1 4, 
Da y 2 1, Da y 
3 0, Da y 6 0,  
a n d at E O T 
after i n de x date 
Disc har ge 
fr o m i n de x 
h os pitalizati o n  
Da y 3 0 a n d 
Da y 6 0 after 
disc har ge  
E n d of 
o bser vati o n  
Ce ntral la b 
eval uati o n  
Disc har ge dia g n osis  
 
 
 
 
 
 
 
Rea d missi o n  
 
 
 
 
 
 
 
Cli nical o utc o me  
 
 
 
 
 
 
 
Micr o bi ol o gic 
o utc o me  
 
 
 
 
 
 
 
 
0 9 0 1 7 7 e 1 9 a 3 c 6 af 0\ A p pr o v e d\ A p pr o v e d O n: 2 3- M a y- 2 0 2 2 0 9: 4 5 ( G M T)