Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
Riverside University Health System Medical Center
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.
Description
Protocol Synopsis General: Enteral vancomycin has gained attention as a promising strategy for preventing healthcare facility-onset Clostridioides difficile infection (HCFO-CDI) in patients during systemic antibiotic exposure in certain high-risk populations. However, data remain scarce for its use as primary prophylaxis. Our study aims to fill this gap and evaluate whether enteral vancomycin prophylaxis can reduce the incidence of HCFO-CDI in critically ill patients along with other relevant clinical outcomes. Study Population: Study subjects will include hospitalized subjects with signific…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- DrugVancomycin 125mg
Vancomycin 125 mg orally daily
- DrugPlacebo
Syrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator.
Location
- Riverside University Health SystemMoreno Valley, California