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.