Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
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
2 other identifiers
interventional
204
8 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Shorter than P25 for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2008
CompletedFirst Posted
Study publicly available on registry
September 15, 2008
CompletedStudy Start
First participant enrolled
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedJuly 3, 2018
June 1, 2018
8 months
September 11, 2008
May 7, 2018
June 29, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary Outcomes (8)
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit
Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Microbiological Response at the End of IV Therapy
End of IV therapy: From Day 5 to Day 14
Number of Participants With Microbiological Response at the Late Follow-up Visit
Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
- +3 more secondary outcomes
Study Arms (2)
NXL104/CAZ/MTZ
EXPERIMENTALNXL104/ceftazidime + metronidazole
Meropenem
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- complicated intra-abdominal infections
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (45)
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center Dept of Surgery
Los Angeles, California, United States
Michael S. Somero Research Division
Palm Springs, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercury Street Medical Group
Butte, Montana, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Summa Health Systems
Akron, Ohio, United States
Remington-Daviss Inc
Columbus, Ohio, United States
ID Clinical Research Ltd
Toledo, Ohio, United States
UMHAT Sveti Georgi 3rd Clinical of Surgery
Plovdiv, Bulgaria
MHAT Rousse, 2nd Clinical of Surgery
Rousse, Bulgaria
CCB Ministry of Interior Clinical of Surgery
Sofia, Bulgaria
Multiprofile Hospital for Active Trt Emergency Med
Sofia, Bulgaria
UMHAT Queen Joanna-ISUL, Clinical of Surgery
Sofia, Bulgaria
Hospital Saint Joseph Marseille
Marseille, France
Hospital L'Archet II
Nice, France
CHU Nimes
Nîmes, France
Medisurge Hospital Ahmedabad
Ahmedabad, India
Medisys Clinisearch India Pvt Ltd
Bangalore, India
MS Ramaiah Memorial Hospital Bangalore
Bangalore, India
Victoria Hospital Bangalore
Bangalore, India
Suyash Hospital Indore
Indore, India
SR Kalla General and Gastro Hospital
Jaipur, India
Amrita Institute of Medical Sciences, Cochin
Kochi, India
Lucknow Cancer Institute Lucknow
Lucknow, India
Al-Zahraa university Hospital
Beirut, Lebanon
Makassed General Hospital
Beirut, Lebanon
Rafik Heriri University Hospital
Beirut, Lebanon
Hammound Hospital University Medical Center
Saida, Lebanon
Labib Medical Center
Saida, Lebanon
Slaski Uniwersytet Medyczny
Katowice, Poland
Pomorskie Centrum Traumatologii
Nowe Ogrody, Poland
Katedra i Klinika Chirurgii Ogolnej
Warsaw, Poland
Samodzielny Publiczny
Warsaw, Poland
Akademicki Szpital Kliniczn
Wroclaw, Poland
Coltea Clinical Hospital
Bucharest, Romania
Floreasca Clinical Emergency Hospital
Bucharest, Romania
Fundeni Clinical Institute
Bucharest, Romania
University Emergency Hospital Bucharest
Bucharest, Romania
City Clinical Hospital # 13
Moscow, Russia
City Clinical Hospital # 1
Moscow, Russia
FGU National Medical Surgery
Moscow, Russia
Moscow City Clinical Hospital # 31
Moscow, Russia
SMO of Clinical Trials
Smolensk, Russia
North-Ossetian Medical Academy
Vladikavkas, Russia
Related Publications (1)
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.
PMID: 30061279DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2008
First Posted
September 15, 2008
Study Start
March 31, 2009
Primary Completion
November 30, 2009
Study Completion
December 31, 2009
Last Updated
July 3, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-06