Complicated Intra-Abdominal Infection | Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Complicated Intra-Abdominal Infection research study
What is the primary objective of this study?
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Who is eligible to participate?
Inclusion Criteria: - 18 to 90 years of age inclusive - Female patient is authorized to participate if at least one of the following criteria are met: 1. Surgical sterilization 2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments 3. Age <50 years and postmenopausal as defined by documented LH and FSH levels in the postmenopausal range PLUS amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments 4. Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of IV study therapy - Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis - Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections Exclusion Criteria: - Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious - Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation - Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis - Patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Complicated Intra-Abdominal Infection
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CAZ-AVICeftazidime 2000 mg and 500 mg of avibactam
Drug:Metronidazole500 mg of Metronidazole
Drug:Meropenem1 gram of Meropenem
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
CAZ-AVI + MetronidazoleIV treatment
Start Date: March 2012
Completed Date: April 2014
Phase: Phase 3
Primary Outcome: Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).
Secondary Outcome: Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set
Study sponsors, principal investigator, and references
Principal Investigator: Paul Newell, MBBS, MRCP
Lead Sponsor: Pfizer
Collaborator: Forest Laboratories
Mazuski JE, Gasink LB, Armstrong J, Broadhurst H, Stone GG, Rank D, Llorens L, Newell P, Pachl J. Efficacy and Safety of Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection: Results From a Randomized, Controlled, Double-Blind, Phase 3 Program. Clin Infect Dis. 2016 Jun 1;62(11):1380-1389. doi: 10.1093/cid/ciw133. Epub 2016 Mar 8.