JAC-antimicrobial resistance · 2026
Randomized double-blind clinical trial evaluating the effectiveness and safety of secondary prophylaxis with oral vancomycin versus placebo in the prevention of recurrence of clostridioides difficile infection in patients receiving systemic antibiotic therapy (PREVAN trial).
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
San-Juan Rafael, Origüen Julia, Fernández-Ruiz Mario, Campion Karen, Silva Jose Tiago, López-Medrano Francisco, Villa Jennifer, Díaz-Pollan Beatriz, Callejas-Díaz Alejandro, Candela Giancarlo, Boan Jorge, Aparicio-Minguijon Eduardo, Pérez-Jacoiste Asin María Asunción, Rodriguez-Goncer Isabel, Martín-Arriscado Cristina, Ferrari José Miguel, Aguado José María
Аннотация
BACKGROUND: Recurrence of Clostridioides difficile infection (CDI) is frequent, particularly in patients requiring subsequent systemic antibiotics. Observational studies suggest that secondary prophylaxis with oral vancomycin (SPV) may reduce recurrence risk, but randomized evidence remains scarce.
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 (P = 0.30). CDI recurrence-free survival at 60 days was 83% (95% CI 48-95) with SPV versus 42% (95% CI 6-77) with placebo (log-rank P = 0.09). No treatment-related serious adverse events were observed; one mild diarrhoeal event occurred in a placebo-treated patient.
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.
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 (P = 0.30). CDI recurrence-free survival at 60 days was 83% (95% CI 48-95) with SPV versus 42% (95% CI 6-77) with placebo (log-rank P = 0.09). No treatment-related serious adverse events were observed; one mild diarrhoeal event occurred in a placebo-treated patient.
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.