Status:
COMPLETED
Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
Lead Sponsor:
Julia Orígüen
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Clostridioides Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05320068
Start Date
August 2 2022
End Date
March 1 2024
Last Update
December 12 2024
Active Locations (1)
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1
Rafael San Juan
Madrid, Madrid, Spain, 28032