Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Condition: Complicated Intra-Abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: CAZ-AVI; Metronidazole; Meropenem
Intervention description: Ceftazidime 2000 mg and 500 mg of avibactam; 500 mg of Metronidazole; 1 gram of Meropenem
Intervention MeSH terms: Metronidazole; Meropenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Ceftazidime; Meropenem; Metronidazole; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; cIAI, Complicated Intra-Abdominal Infection

Summary:

      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.
    

Eligibility criteria:

        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