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

December 9, 2024 updated by: Julia Orígüen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28032
        • Rafael San Juan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Hypersensitivity to vancomycin
  • Inability to comply with 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
  • Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days
  • Therapy with oral vancomycin or any other agent with activity against C. difficile for >48 hours in the previous 3 days;.
  • Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility
  • Systemic antibiotic therapy for 72 hours or more before the recruitment
  • Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
  • Estimated use of systemic antibiotic therapy for more than 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.
Drug: Oral Vancomycin
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
Placebo Comparator: Placebo group
A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
Drug: Placebo
A blinded capsule that contains no vancomycin every 6 hours during 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Time Frame: 60 days after the beginning of the intervention
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
60 days after the beginning of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences
Time Frame: 60 days after the beginning of the intervention
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by index CDI episode (first episode or recurrence)
60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence
Time Frame: 60 days after the beginning of the intervention
The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo
60 days after the beginning of the intervention
Effectiveness of treatment with oral vancomycin depending on antibiotic therapy
Time Frame: 60 days after the beginning of the intervention
The absolute difference in the rate of C. difficile infection recurrences with vancomycin vs placebo stratified by the type of systemic antibiotic therapy prescribed.
60 days after the beginning of the intervention
Tolerance and safety of treatment with oral vancomycin
Time Frame: 60 days after the beginning of the intervention
Rate of major adverse events and drug-related adverse events.
60 days after the beginning of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julia Orígüen

Collaborators

Instituto de Salud Carlos III

Investigators

  • Study Chair: RAFAEL SAN-JUAN, Hospital 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVAN-ICD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared

IPD Sharing Time Frame

Data generated by the research will be made available as soon as possible, wherever legally and ethically possible. It is Planned to share data starting 9 months after publication, and data will be available for 24 months thereafter.

IPD Sharing Access Criteria

IPD will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to rafael.san@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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