Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: Ceftazidime-avibactam; metronidazole; Meropenem
Intervention description: Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg; Metronidazole 500mg/100ml solution for infusion; Meropenem powder for solution for infusion 1000mg
Intervention MeSH terms: Metronidazole; Meropenem; Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 486.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Ceftazidime-avibactam,; Metronidazole,; Meropenem,; Anti-Bacterial Agents,; Anti-Infective Agents,; Therapeutic Uses,; Pharmacologic Actions,; Physiological Effects of Drugs

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:

          -  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