Rafael San Juan
Madrid, 28032, Spain
NCT Number: NCT05320068
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Madrid, 28032, Spain
As secondary objectives the investigators intend to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A blinded capsule that contains 125mg of vancomycin every 6 hours during 10 days.
A blinded capsule that contains no vancomycin every 6 hours during 10 days.
Time frame: 60 days after the beginning of the intervention
Absolute difference in the rate of C. difficile infection recurrences with vancomycin Vs placebo.
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)
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
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.
Time frame: 60 days after the beginning of the intervention
Rate of major adverse events and drug-related adverse events.
Julia Orígüen
Other
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
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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