NCT05320068

Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Julia Orígüen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As secondary objectives the investigators intend to: * Evaluate the effectiveness of the treatment with oral vancomycin as part of the prophylaxis arsenal to prevent ICD in patients with previous ICD episodes stratified by the number of previous recurrences. * Compare the severity of recurrences in both study groups. * Compare the effectiveness of the treatment with oral vancomycin depending on the type of systemic antibiotic therapy prescribed. * Evaluate the tolerance and the safety of the treatment with oral vancomycin in terms of secondary effects and difficulty in therapeutic compliance. * Evaluate if the treatment with oral vancomycin has an effect in diminishing the severity of ICD recurrences.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DRUG	Oral Vancomycin	A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
DRUG	Placebo	A blinded capsule that contains no vancomycin every 6 hours during 10 days.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-04-11
• Last updated: 2024-12-12

Locations

1 site across 1 country: Spain