Clinical trial NCT00752219: Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Official title: A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complicated Intra-abdominal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.


Eligibility criteria: Inclusion Criteria:

* complicated intra-abdominal infections

Exclusion Criteria:

* infections limited to hollow viscus
* ischemic bowel disease without perforation
* acute suppurative cholangitis
* acute necrotizing pancreatitis
* pts to undergo stated abdominal repair, open abdomen technique or marsupialization
* Apache II \>25

Primary outcomes:
measure: Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
timeFrame: Test of cure visit: 2 weeks post-therapy (Day 28)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary outcomes:
measure: Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
timeFrame: End of IV therapy: From Day 5 to Day 14
measure: Number of Participants With Clinical Response at the Late Follow-up Visit
timeFrame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
measure: Number of Participants With Microbiological Response at the Test of Cure Visit
timeFrame: Test of cure visit: 2 weeks post-therapy (Day 28)
measure: Number of Participants With Microbiological Response at the End of IV Therapy
timeFrame: End of IV therapy: From Day 5 to Day 14
measure: Number of Participants With Microbiological Response at the Late Follow-up Visit
timeFrame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
measure: Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
timeFrame: Test of cure visit: 2 weeks post-therapy (Day 28)
measure: Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
timeFrame: End of IV therapy: From Day 5 to Day 14
measure: Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
timeFrame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center Dept of Surgery
state: California
city: Palm Springs
country: United States
facility: Michael S. Somero Research Division
state: California
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Akron
country: United States
facility: Summa Health Systems
state: Ohio
city: Columbus
country: United States
facility: Remington-Daviss Inc
state: Ohio
city: Toledo
country: United States
facility: ID Clinical Research Ltd
state: Ohio
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi 3rd Clinical of Surgery
city: Rousse
country: Bulgaria
facility: MHAT Rousse, 2nd Clinical of Surgery
city: Sofia
country: Bulgaria
facility: CCB Ministry of Interior Clinical of Surgery
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Trt Emergency Med
city: Sofia
country: Bulgaria
facility: UMHAT Queen Joanna-ISUL, Clinical of Surgery
city: Marseille
country: France
facility: Hospital Saint Joseph Marseille
city: Nice
country: France
facility: Hospital L'Archet II
city: Nimes
country: France
facility: CHU Nimes
city: Ahmedabad
country: India
facility: Medisurge Hospital Ahmedabad
city: Bangalore
country: India
facility: Medisys Clinisearch India Pvt Ltd
city: Bangalore
country: India
facility: MS Ramaiah Memorial Hospital Bangalore
city: Bangalore
country: India
facility: Victoria Hospital Bangalore
city: Cochin
country: India
facility: Amrita Institute of Medical Sciences, Cochin
city: Indore
country: India
facility: Suyash Hospital Indore
city: Jaipur
country: India
facility: SR Kalla General and Gastro Hospital
city: Lucknow
country: India
facility: Lucknow Cancer Institute Lucknow
city: Beirut
country: Lebanon
facility: Al-Zahraa university Hospital
city: Beirut
country: Lebanon
facility: Makassed General Hospital
city: Beirut
country: Lebanon
facility: Rafik Heriri University Hospital
city: Saida
country: Lebanon
facility: Hammound Hospital University Medical Center
city: Saida
country: Lebanon
facility: Labib Medical Center
city: Katowice
country: Poland
facility: Slaski Uniwersytet Medyczny
city: Nowe Ogrody
country: Poland
facility: Pomorskie Centrum Traumatologii
city: Warszawa
country: Poland
facility: Katedra i Klinika Chirurgii Ogolnej
city: Warszawa
country: Poland
facility: Samodzielny Publiczny
city: Wroclaw
country: Poland
facility: Akademicki Szpital Kliniczn
city: Bucharest
country: Romania
facility: Coltea Clinical Hospital
city: Bucharest
country: Romania
facility: Floreasca Clinical Emergency Hospital
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: University Emergency Hospital Bucharest
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 13
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 1
city: Moscow
country: Russian Federation
facility: FGU National Medical Surgery
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 31
city: Smolensk
country: Russian Federation
facility: SMO of Clinical Trials
city: Vladikavkas
country: Russian Federation
facility: North-Ossetian Medical Academy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.