Oral Vancomycin to Prevent Clostridioides difficile Infection in Critically Ill Adults at High Risk

What this Trial Is About

Researchers are evaluating whether oral vancomycin can prevent Clostridioides difficile infection C. diff in adults who are critically ill and at high risk due to their medical conditions and hospital stay. This trial also aims to understand the safety of vancomycin in this setting. The main questions are whether vancomycin lowers the infection rate and how carrier status of C. diff affects infection and clearance when vancomycin is used as primary prevention. Participants will be randomly assigned to receive either oral vancomycin 125 mg daily or a matching placebo while they are on systemic antibiotics, continuing up to five days after the last antibiotic dose, with the antibiotic treatment not exceeding 21 days. If discharged before completing the study medication, participants will continue taking it at home. Stool samples or rectal swabs will be collected to assess C. diff carrier status and changes in stool microbiome, including vancomycin-resistant Enterococcus VRE. During the study, participants will be monitored every three days until hospital discharge for adherence and side effects. After finishing the treatment, follow-up calls will be made to check for diarrhea or any adverse effects. The primary outcome is the rate of healthcare facility-onset C. diff infection, measured up to four months, along with secondary outcomes like VRE colonization, community-onset infections, time to infection in symptomatic patients, colonization at discharge, hospital stay length, and in-hospital mortality.

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