Use of Ribaxamase (SYN-004), a beta lactamase, to prevent Clostridium difficile infection in Beta lactam treated patients: a double blind phase randomized placebo controlled trial
Beta lactam antibiotics are considered risk factors for clostridioides difficile infection. These antibiotics are excreted by the bile in the gut and maintain antibiotic levels at this site. Ceftriaxone is highly excreted by the biliary tree. This excretion can continues up to 48 hours after discontinuation of intravenous ceftriaxone and may lead to concentrations as high as 1 mg/ml in the intestinal fluid. Ribaxamase degrades beta lactams and could help preventing C diff infection. This was a study including 433 patients selected randomly from 44 different clinical centers to receive either ceftriaxone plus placebo or ceftriaxone plus Ribaxamase. At the end of the study there were half of cases of C diff infection in the Ribaxamase group, and as a bonus, a similar decrease of vancomycin resistant enterococci colonization, as evaluated in the same group of patients who showed extended spectrum gram-negative bacilli with the same quantity in feces. Essentially, there were no side effects of the enzyme, but the group receiving the enzyme had some more cardiac deaths, but, apparently, unrelated to the treatment.
Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, et al. Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: a double-blind, phase 2b randomized placebo-controlled trial. Lancet Infect Dis. 2019;19(5):487-96. https://doi.org/10.1016/S1473-3099(18)30731-X