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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
United States
California
Riverside University Health System
RECRUITING
Moreno Valley
Contact Information
Primary
Suman Thapamagar, MD
suman.thapamagar@ruhealth.org
9514864000
Backup
Brian Phan, PharmD
b.phan@ruhealth.org
9514864000
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 176
Treatments
Active_comparator: Oral Vancomycin 125 mg (liquid)
Oral Vancomycin 125 mg (liquid) daily
Placebo_comparator: Placebo oral (liquid)
Oral Placebo (liquid) daily.
Related Therapeutic Areas
Sponsors
Leads: Riverside University Health System Medical Center

This content was sourced from clinicaltrials.gov