A new study, published in The Lancet Infectious Diseases, assessed the safety and efficacy of ridinilazole, as compared to vancomycin for treating Clostridium difficile infections.
Researchers conducted a phase II, randomized, double-blind, non-inferiority study including participants from 33 centers in the U.S. and Canada. The study includes patients with signs of C. diff infection and a positive diagnostic test result.
Between June 26, 2014, and Aug. 31, 2015, researchers recruited 100 patients, of which 50 were randomly assigned to receive oral ridinilazole and 50 to receive oral vancomycin. Sixteen patients did not complete the study, and 11 discontinued treatment early.
Here are four insights:
1. Twenty-four of 36 patients (66.7 percent) in the ridinilazole group had a sustained clinical response, versus 14 of 33 patients (42.4 percent) in the vancomycin group.
2. The above finding established the non-inferiority of ridinilazole.
3. Additionally, ridinilazole was as well-tolerated as vancomycin — with 82 percent of participants in the ridinilazole group and 80 percent of those in the vancomycin group reporting adverse events.
4. There were no adverse events related to ridinilazole that led to discontinuation.
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