Combination Antibiotic Effective for Complicated Intra-Abdominal Infections
Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).
RECLAIM-1 and -2 are randomized, multi-center, double-blind, double-dummy, parallel-group, comparative studies designed to determine the efficacy, safety, and tolerability of ceftazidime-avibactam plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections in 1,066 hospitalized adults. The primary endpoint was a clinical cure rate 28–35 days after randomization.
The primary endpoint of statistical non-inferiority for ceftazidime-avibactam compared to meropenem was met in both trials. Also, ceftazidime-avibactam was effective in treating cIAI patients infected with ceftazidime-resistant bacteria.
The investigational antibiotic combination consists of ceftazidime, a cephalosporin and avibactam, a next generation non-beta lactam beta-lactamase inhibitor. The combination drug is being developed to treat a broad range of gram-negative bacterial infections, which are becoming resistant to antibiotics. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
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