WithdrawnPhase 2/3

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

Stopped: Recruitment for end-points deemed not feasible.

United States0Started 2027-01-01

Plain-language summary

The purpose of this study is to evaluate the ability of oral vancomycin in preventing Clostridioides difficile infection (CDI) in patients that are simultaneously receiving antibiotics. Participants in this study will be placed randomly into two groups. The oral vancomycin treatment group will receive oral vancomycin two times per day simultaneously with an antibiotic plus two additional days. The no oral vancomycin control group will receive the current standard of care, which is an antibiotic and no oral vancomycin. Participation in this study will last approximately 3 months.

Who can participate

Age range

65 Years – 100 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 65 years or older * Receive systemic antibiotics in the last 90 days * Hospitalized anywhere in the last 90 days * History of C diff colonization without history of C diff colitis (infection) * Provide informed consent * Read and understand the English language * Not current taking probiotics * Lack of allergy or contraindications to receive vancomycin * Ability to take oral medications * Not receiving medications that can be used to treat or prevent C diff Exclusion Criteria: * Age 64 years or younger * Has not received systemic antibiotics in the last 90 days * Has not been hospitalized in the last 90 days * History of C diff colonization with a history of C diff colitis (infection) * Not provided informed consent * Cannot read and understand the English language * Currently receiving probiotics * Allergy or contraindications to receive vancomycin * Unable to take oral medications * Receiving medications that can be used to treat or prevent C diff

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.

1This trial is testing oral vancomycin to prevent C. diff infection while someone is already on another antibiotic — given my situation, does my doctor think I'm actually at high enough risk of C. diff to consider a preventive approach like this?
2One of the known concerns with using vancomycin widely is the risk of encouraging resistant bacteria, and this trial is specifically tracking vancomycin-resistant Enterococcus faecium as a potential consequence — how worried should I be about that risk, and how would it be monitored if I were in a study like this?
3Since this trial is Phase 2/3 and hasn't started recruiting yet, what does that mean for how much is already known about the safety and effectiveness of using oral vancomycin this way — and are there existing options my doctor already trusts for C. diff prevention?
4Because this study isn't recruiting yet, is there a standard-of-care approach my doctor would recommend right now instead of waiting to see if I might eventually be eligible for a trial like this?
5If my doctor thinks preventive treatment for C. diff makes sense for me, how would being in a trial like this — where I might or might not receive the vancomycin — compare to simply being prescribed it directly outside of a study?

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

Number of participants who develop C diff after receiving oral vancomycin plus another antibiotic at the same time versus participants who do not receive oral vancomycin

Timeframe: Hospitalization duration and through 90 days post hospitalization discharge

Trial details

NCT IDNCT07221708

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Clostridioides Difficile trials