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Preventing C. diff Infection with Oral Vancomycin

This study is looking at whether a medicine called vancomycin, taken by mouth, can prevent a serious gut infection called Clostridioides difficile (C. diff) in critically ill adults. You might be able to join if you are 18 or older, have been in the hospital for at least 3 days, are taking antibiotics, and have other risk factors like being over 65. Researchers want to see if oral vancomycin lowers the number of C. diff infections compared to a placebo (a look-alike substance with no medicine). The study will also check how safe vancomycin is in this group of patients. The main goal is to see if vancomycin can reduce C. diff infections that start in the hospital, with results measured for up to 4 months.

Study design
This is an interventional study that will compare oral vancomycin to a placebo. It plans to enroll 176 participants.
What's involved
Participants will receive vancomycin 125 mg orally daily or a placebo for up to five days after their last dose of systemic antibiotic.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, C. diff infection, will be measured for up to 4 months.

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NCT07221370

Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients

Recruiting
PHASE2Ages 18+InterventionalPrevention
Riverside University Health System Medical Center
~176 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Vancomycin 125mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).
Measured over up to 4 months

Conditions

Clostridium Difficile Infection
Vancomycin Resistant Enterococci Infection

Explore related trials

Clostridium difficile InfectionInfection caused by vancomycin resistant Enterococcus

Where it's being run

1 sites across 1 states
California1

Who to contact

Suman Thapamagar, MD
[email protected]
9514864000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults aged 18 years and older.
Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
Admitted ≥ 72 hours into their index hospitalization. 2. And must meet 2 additional of the following high-risk criteria
Age ≥ 65 years
Previous residence in long-term care facility
Previous proton pump inhibitor use (chronic or as needed)
Inflammatory bowel disease
Immunocompromised state (HIV/AIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)
End stage renal disease (ESRD)
Diabetes mellitus
Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg/min)
Hospitalized ≤ 30 days prior to the index hospitalization.
Received systemic antibiotics during that prior hospitalization.

Exclusion

Pregnant or breastfeeding women
Currently incarcerated individuals
Individual or legal representative whose informed consent cannot be obtained
Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
Receiving concurrent treatment with metronidazole for any indication
One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
Receiving concurrent probiotics
Allergic reaction or had a contraindication for use of enteral vancomycin
History of prior CDI within the past 90 days of randomization
Had suspected active CDI prior to inclusion
Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization

What this trial measures

  • Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).up to 4 months

    Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction \[PCR\] and stool toxin test) \> 72 hours into hospitalization.