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

Part of paid clinical trials in Moreno Valley, California.

Sponsor
Riverside University Health System Medical Center
Study ID
NCT07221370
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Clostridium Difficile Infection
  • Vancomycin Resistant Enterococci Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin 125mg — DRUG
    Vancomycin 125 mg orally daily
  • Placebo — DRUG
    Syrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator.

Study Details

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.

Key Dates

Start date
Oct 21, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Oral Vancomycin 125 mg (liquid)
    Oral Vancomycin 125 mg (liquid) daily
  • Placebo Comparator: Placebo oral (liquid)
    Oral Placebo (liquid) daily.

Primary Outcome Measure

Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI). [ Time Frame: up to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riverside University Health SystemMoreno ValleyCalifornia92373
Suman B Thapamagar, MBBS
[email protected]
9514864000
Brian Phan, PharmD
[email protected]
9514864000
Suman Thapamagar, MBBS (PRINCIPAL_INVESTIGATOR)
Brian Phan, PharmD (SUB_INVESTIGATOR)

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By research site
Riverside University Health System· Moreno Valley, CA

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