Conditions: Complicated Intra-abdominal Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CXA-101/ tazobactam and metronidazole intervention 2: meropenem plus saline placebo
Intervention descriptions: intervention 1: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion intervention 2: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion

Protocol document: