Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: CXA-201 and metronidazole; Meropenem
Intervention description: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days; Meropenem IV infusion (1000mg q8h) for 4-14 days
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: 494.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cIAI

Summary:

      This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of
      CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus
      meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections
      (cIAI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnoses of cIAI.

          -  Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or
             percutaneous draining of an abscess) within 24 hours of (before or after) the first
             dose of study drug.

        Exclusion Criteria:

          -  Simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis;
             pancreatic abscess; or pelvic infections.

          -  Complicated intraabdominal infection managed by staged abdominal repair (STAR), open
             abdomen technique including temporary closure of the abdomen, or any situation where
             infection source control is not likely to be achieved.

          -  Use of systemic antibiotic therapy for IAI for more than 24 hours prior to the first
             dose of study drug, unless there is a documented treatment failure with such therapy.

          -  Have a concomitant infection at the time of randomization, which requires non-study
             systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only
             gram-positive activity [e.g., daptomycin, vancomycin, linezolid] are allowed).

          -  Severe impairment of renal function (estimated CrCl < 30 mL/min), or requirement for
             peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine
             output over 24 hours).

          -  The presence of hepatic disease at baseline.

          -  Considered unlikely to survive the 4 to 5 week study period.

          -  Any rapidly-progressing disease or immediately life-threatening illness (including
             respiratory failure and septic shock).

          -  Have a documented history of any moderate or severe hypersensitivity or allergic
             reaction to any β-lactam antibacterial (a history of a mild rash followed by
             uneventful re-exposure is not a contraindication to enrollment), including
             cephalosporins, carbapenems, penicillins, or ß-lactamase inhibitors, or metronidazole,
             or nitroimidazole derivatives.

          -  Women who are pregnant or nursing.