Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
NCT ID: NCT05320068
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2022-08-02
2024-03-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention group
A group of patients will be treated with a blinded capsule that contains 125mg of vancomycin every 6 hours for 10 days.
Oral Vancomycin
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
Placebo group
A group of patients will be treated with a blinded capsule that contains a placebo every 6 hours for 10 days.
Placebo
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
Interventions
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Oral Vancomycin
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
Placebo
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Julia Orígüen
OTHER
Responsible Party
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Julia Orígüen
Julia Origüen Sabater, MD, PhD, Principal Investigator.
Principal Investigators
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RAFAEL SAN-JUAN
Role: STUDY_CHAIR
HOSPITAL 12 DE OCTUBRE
Locations
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Rafael San Juan
Madrid, Madrid, Spain
Countries
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References
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Other Identifiers
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PREVAN-ICD
Identifier Type: -
Identifier Source: org_study_id