At a glance
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Phase III,randomized,double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Vs Placebo in the Prevention of Recurrence of C.difficile Infection in Patients Under Treatment with Systemic Antibiotic Therapy
In Brief
A Phase 3 clinical trial evaluating Oral Vancomycin and Placebo for Clostridioides Difficile Infection. Completed, enrolled 24 participants across 1 site.
Detailed Summary
A phase III randomized clinical trial in proportion 2:1 in favor of oral vancomycin (experimental treatment), multicentric, national, double-blinded, controlled with placebo. The main objective is to evaluate the effectiveness of treatment with oral vancomycin to reduce the incidence of Clostridioides difficile infection (CDI) in patients who suffered previous CDI and who need further hospitalization and treatment with systemic antibiotic therapy in the 90 days after the first CDI.
Study Details
Timeline
Interventions
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
A blinded capsule that contains no vancomycin every 6 hours during 10 days.