Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT05320068
- Lead Sponsor
- Julia Orígüen
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Oral Vancomycin A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days. Placebo group Placebo A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
- Primary Outcome Measures
Name Time Method Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile 60 days after the beginning of the intervention Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
- Secondary Outcome Measures
Name Time Method Effectiveness of treatment with oral vancomycin depending on antibiotic therapy 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.
Effectiveness of treatment with oral vancomycin according to the number of previous recurrences 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)
Effectiveness of treatment with oral vancomycin in diminishing the severity of the recurrence 60 days after the beginning of the intervention The absolute difference in the rate of severe C. difficile infection recurrences with vancomycin vs placebo
Tolerance and safety of treatment with oral vancomycin 60 days after the beginning of the intervention Rate of major adverse events and drug-related adverse events.
Trial Locations
- Locations (1)
Rafael San Juan
🇪🇸Madrid, Spain