Complicated Intra-abdominal Infection | Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd 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: - Patient must be 18 to 90 years of age, inclusive, - Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy - Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose - Intraoperative/postoperative enrollment with visual 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 indicators; 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 - Patients whose surgery will include staged abdominal repair, or \"open abdomen\" technique, or marsupialization - 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:Ceftazidime-avibactamCeftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
Drug:metronidazoleMetronidazole 500mg/100ml solution for infusion
Drug:MeropenemMeropenem powder for solution for infusion 1000mg
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.
Ceftazidime-Avibactam plus metronidazole
Start Date: January 2013
Completed Date: March 2015
Phase: Phase 3
Primary Outcome: The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
Secondary Outcome: The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.
Study sponsors, principal investigator, and references
Principal Investigator: Paul A Newell, MBBS, MRCP
Lead Sponsor: Pfizer