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

NCT05320068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Clostridioides Difficile Infection

Interventions

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Julia Orígüen

    lead OTHER

Principal Investigators

  • RAFAEL SAN-JUAN · HOSPITAL 12 DE OCTUBRE

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320068 on ClinicalTrials.gov