CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Oral Vancomycin +1 moredrug
Likely dose
Oral Vancomycin 125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05320068
NCT05320068Phase 3Completed

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

Julia Orígüen·interventional·Posted Apr 11, 2022·Updated Dec 12, 2024

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedApr 11, 2022
Enrollment StartAug 2, 2022
Primary CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.2 years ago

Interventions

Oral Vancomycindrug

A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.

Placebodrug

A blinded capsule that contains no vancomycin every 6 hours during 10 days.