Conditions: Complicated Intra-abdominal Infection
Keywords: cIAI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 494
Healthy volunteers: no

Brief 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).

Detailed description:
Approximately, 500 subjects will be enrolled into this study, randomized 1:1 to receive CXA-201 and metronidazole or comparator (meropenem). Subject participation will require a minimum commitment of 38 days and a maximum of 45 days. An End of Treatment (EOT) visit will occur within 24 hours following the last dose of study drug administration/drug discontinuation. A Test of Cure (TOC)/Safety visit will be conducted 26 to 30 days following the first dose of study drug administration. A Last Follow-up (LFU) visit will be conducted 38 to 45 days after the first dose of study drug.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CXA-201 and metronidazole intervention 2: Meropenem
Intervention descriptions: intervention 1: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days intervention 2: Meropenem IV infusion (1000mg q8h) for 4-14 days

Protocol document: