Clinical trial NCT01808092: A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Official title: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nosocomial Pneumonia (NP)
Ventilator-associated Pneumonia (VAP)
Keywords: Ceftazidime,
Meropenem,
Anti-Bacterial Agents,
Anti-Infective Agents,
Therapeutic Uses,
Pharmacologic Actions,
Physiological Effects of Drugs
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 969
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

Detailed description: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Eligibility criteria: Inclusion Criteria:

* 18 to 90 years of age inclusive
* Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
* Onset of symptoms ≥ 48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility
* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization
* At least 1 of the following systemic signs:Fever (temperature \>38 C) or hypothermia (rectal/core temperature \<35 C); White blood cell count \>10,000 cells/mm3, or White blood cell count \<4500 cells/mm3, or \>15% band forms.

Exclusion Criteria:

* Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
* Patients with lung abscess, pleural empyema or post obstructive pneumonia.
* Patients with an estimated creatinine clearance \<16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
* Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
* Patients receiving hemodialysis or peritoneal dialysis.

Primary outcomes:
measure: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
Secondary outcomes:
measure: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set
timeFrame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
timeFrame: At the test-of-cure (TOC) visit (Day 21 to 25)
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28
timeFrame: at Day 28 from randomization
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28
timeFrame: at Day 28 from randomization
measure: The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28
timeFrame: at Day 28 from randomization
measure: The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set
timeFrame: up to 25 days from randomization
measure: The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set
timeFrame: up to 25 days from randomization
measure: The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set
timeFrame: up to 25 days from randomization
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Florida
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Campinas/SP
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: São José do Rio Preto
country: Brazil
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Jiangyin
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Sanya
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xiamen
country: China
facility: Research Site
city: Yangzhou
country: China
facility: Research Site
city: Zhanjiang
country: China
facility: Research Site
city: Kolin
country: Czechia
facility: Research Site
city: Kyjov
country: Czechia
facility: Research Site
city: Praha 10, Prague
country: Czechia
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris 14
country: France
facility: Research Site
city: Paris Cedex
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Poitiers Cedex
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Veszprém
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Lucknow
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Varanasi
country: India
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Higashiibaraki-gun
country: Japan
facility: Research Site
city: Ikeda-shi
country: Japan
facility: Research Site
city: Itabashi-ku
country: Japan
facility: Research Site
city: Izumo-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Kitakyushu-shi
country: Japan
facility: Research Site
city: Kushiro-shi
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Saga-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sasebo-shi
country: Japan
facility: Research Site
city: Tsuchiura-shi
country: Japan
facility: Research Site
city: Tsukubo-gun
country: Japan
facility: Research Site
city: Uji-shi
country: Japan
facility: Research Site
city: Uki-shi
country: Japan
facility: Research Site
city: Yanai-shi
country: Japan
facility: Research Site
city: Ansan-si
country: Korea, Republic of
facility: Research Site
city: Anyang-si
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jinju-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Wonju-si
country: Korea, Republic of
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Cusco
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chrzanów
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Suwałki
country: Poland
facility: Research Site
city: Łęczna
country: Poland
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Zelenograd
country: Russian Federation
facility: Research Site
city: Golnik
country: Slovenia
facility: Research Site
city: Randburg
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sabadell(Barcelona)
country: Spain
facility: Research Site
city: Terrassa (Barcelona)
country: Spain
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Mykolayiv
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hochiminh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Joseph Chow, MD, FIDSA
role: STUDY_DIRECTOR
References:
citation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
citation: Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.
citation: Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.
citation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
citation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
citation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
citation: Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.