Randomized double-blind clinical trial evaluating the effectiveness and safety of secondary prophylaxis with oral vancomycin versus placebo in the prevention of recurrence of

Background: Recurrence of Methods: PREVAN (NCT05320068) was a phase III, double-blind, placebo-controlled randomized clinical trial conducted at a tertiary hospital in Spain. Adults with documented CDI within the previous 180 days who required hospitalization and systemic antibiotics were randomized (2:1) to receive oral vancomycin (125 mg every 6 h) or placebo for 10 days, stratified by type of index CDI episode. Primary endpoints were CDI recurrence within 60 days after end of therapy and CDI recurrence-free survival. Results: Twenty-one patients were enrolled (14 SPV; 7 placebo). Mean age was 73.5 years and 76.7% had malignancy and/or immunosuppression. CDI recurrence occurred in 5 patients (23.8%): 2 (14.3%) in the SPV group and 3 (42.9%) in the placebo group ( Conclusions: In high-risk patients with recent CDI requiring systemic antibiotics, SPV appeared safe and was associated with a clinically relevant reduction in recurrence, although the trial was underpowered. These findings support further adequately powered randomized studies to define the role of SPV in preventing CDI recurrence.