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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rafael San Juan
Madrid, Madrid, Spain
Start Date
August 2, 2022
Primary Completion Date
March 1, 2024
Completion Date
March 1, 2024
Last Updated
December 12, 2024
24
ACTUAL participants
Oral Vancomycin
DRUG
Placebo
DRUG
Lead Sponsor
Julia Orígüen
Collaborators
NCT06237452
NCT05739825
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06306014