Oral vancomycin to prevent C. difficile infection in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial enrolls critically ill adults hospitalized at least 72 hours who have received systemic antibiotics for at least 72 hours and meet additional high-risk criteria for C. difficile. Participants are randomized to receive enteral vancomycin 125 mg daily or a matching placebo while on systemic antibiotics and for up to five days after the last antibiotic dose. Investigators will monitor healthcare facility-onset C. difficile infection rates, C. difficile carriage and clearance using rectal swabs, and safety outcomes including vancomycin-resistant enterococci emergence. The study is designed to test whether short-course prophylactic enteral vancomycin can lower CDI incidence without causing unacceptable harms in this high-risk hospitalized population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must meet all 3 criteria:

   * 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 Criteria:

* 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

Where it's running

• Riverside University Health System
  Moreno Valley, California, United States Recruiting

Study contacts

• Study coordinator: Suman Thapamagar, MD
• Email: suman.thapamagar@ruhealth.org
• Phone: 9514864000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.