Clinical Trials Resource Center

Intra-Abdominal Infections

September 1, 2014

Actavis released results from two phase III studies of ceftazidime-avibactam as a treatment for adult hospitalized patients with complicated intra-abdominal infections. RECLAIM-1 and -2 are phase III, randomized, multi-center, double-blind, double-dummy, parallel-group, comparative studies to determine the efficacy, safety and tolerability of ceftazidime/avibactam (2000mg/500mg, q8h) plus metronidazole (0.5g q8h) versus meropenem (1g q8h) in the treatment of complicated intra-abdominal infections in hospitalized adults. A total of 1,066 patients have been randomized to the RECLAIM-1 and -2 trials from 30 countries.

June 20, 2011

Cubist Pharmaceuticals released results from a phase II trial of CXA-201 for the treatment of complicated intra-abdominal infections. This double blind trial enrolled 122 subjects who received intravenous infusions of CXA-101 plus metronidazole or the active comparator, meropenem, the standard of care. The primary endpoint was clinical response seven to 14 days after end of treatment. In the clinically evaluable population data showed a clinical cure rate of 91% for the CXA-201 treatment arm and 94% for the meropenem arm. In the microbiologically evaluable population, the clinical cure rate was 89% in the CXA-201 arm and 96% in the meropenem arm. CXA-201 was safe and well-tolerated.

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