Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection (NCT05320068) | Clinical Trial Compass
CompletedPhase 3
Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
Spain24 participantsStarted 2022-08-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of treatment with oral vancomycin in the prevention of Clostridioides difficile
Timeframe: 60 days after the beginning of the intervention