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Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: A double-blind, phase 2b, randomised placebo-controlled trial

The Lancet Infectious Diseases May 01, 2019

Kokai-Kun JF, et al. - Researchers performed this parallel-group, double-blind, multicenter, phase 2b, randomized placebo-controlled trial to assess if C difficile infection could be prevented in patients being treated with intravenous ceftriaxone for a lower respiratory tract infection by administering ribaxamase. Patients older than 50 years were randomly assigned to groups (1:1) in blocks of four to receive either 150 mg ribaxamase or placebo four times per day during and for 72 hours following treatment with ceftriaxone. Oral ribaxamase led to a lower incidence of C difficile infections vs placebo in patients treated with intravenous ceftriaxone for lower respiratory tract infections. The groups displayed imbalance in deaths that seems to be connected to the underlying patients’ health. In patients treated with intravenous β-lactam antibiotics, C difficile infection could be prevented using ribaxamase. Continued clinical development of ribaxamase for the prevention of C difficile infection is supported by these findings.

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