NCT07221370 Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 176 participants in total. It began in 2024-10-21 with a primary completion date of 2026-12-31.

Brief Summary

The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are: * Does oral vancomycin lower the rate of C.diff infection in high-risk patients? * Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital. Participants will: * Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days. * When discharged from the hospital, participants will continue to take the study medication in the event he/she did not complete the intended course of the study medication while in the hospital. * Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus) * After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.

Eligibility Criteria

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

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