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NCT Number: NCT05320068

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rafael San Juan

Madrid, 28032, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Vancomycin

Drug

A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.

Placebo

Drug

A blinded capsule that contains no vancomycin every 6 hours during 10 days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Julia Orígüen

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: PREVAN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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