A Phase III, Randomized, Double-blinded Clinical Trial to Evaluate the Effectiveness and Safety of Oral Vancomycin Versus Placebo in the Prevention of Recurrence of C. Difficile Infection in Patients Under Treatment With Systemic Antibiotic Therapy (PREVAN)

  • STATUS
    Recruiting
  • End date
    Jul 20, 2024
  • participants needed
    108
  • sponsor
    Julia Orígüen
Updated on 20 August 2022

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.

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.

Details
Condition Clostridioides Difficile Infection
Treatment Placebo, Oral Vancomycin
Clinical Study IdentifierNCT05320068
SponsorJulia Orígüen
Last Modified on20 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age equal or superior to 18 years
Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
Need for hospitalization and need of antibiotic therapy
Signature of informed consent

Exclusion Criteria

Woman of childbearing age, pregnant woman, or breastfeeding woman
Patients allergic to vancomycin
Impossibility of fulfilling the study protocol
Critically ill condition or life expectancy less than 30 days
Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
Patients that meet diarrhea criteria or that present a Clostridioides Difficile infection at the time of patient's recruitment or during the 3 days prior
Antibiotic therapy with oral vancomycin at the time of patient's selection or during the 3 days prior, or with any drug that is effective against Clostrioides Difficile
Antibiotic prophylaxis with oral vancomycin or with any drug that is effective against Clostrioides difficile during the 90 days before the recruitment
Systemic antibiotic therapy for 72 hours or more before the recruitment
Enrolment in another clinical trial that evaluates other drugs' effectiveness
Estimated use of systemic antibiotic therapy for more than 4 weeks
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