Secondary Prophylaxis of Recurrent Clostridioides Difficile Infections During Systemic Antibiotics With Vancomycin: A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether oral vancomycin can prevent recurrent Clostridioides difficile infections (rCDI) in adults who have recently had CDI (within 120 days) and are exposed again to systemic antibiotics. This is important because antibiotic re-exposure is the strongest risk factor for CDI recurrence, which causes severe diarrhea and significant health and economic burdens. The trial addresses the uncertainty about vancomycin's effectiveness for preventing recurrence during antibiotic use by comparing it to a placebo in a randomized, double-blind study. Participants will be randomly assigned to receive either oral vancomycin or a placebo. Those assigned to vancomycin will take 125 mg twice daily during the systemic antibiotic treatment plus 125 mg once daily for 7 days after completing antibiotics. The placebo group will take matching capsules on the same schedule. The treatment duration depends on the length of the systemic antibiotic therapy. This trial includes follow-up visits and electronic questionnaires to monitor outcomes. Participants will take the study drug during their antibiotic course and for 7 days afterward. They will attend an in-person follow-up visit at day 56 and complete weekly electronic questionnaires to report their health status. Researchers will measure the recurrence of CDI within 56 days as the main outcome, along with later recurrences, mortality, adverse events causing drug discontinuation, and hospital visits within 90 days. The study will monitor participants carefully to assess the safety and effectiveness of prophylactic vancomycin.

Secondary Prevention of Clostridioides Difficile Using Vancomycin