Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID07221370

Enteral Vancomycin as Primary Prevention Against Clostridioides Difficile Infection in Critically Ill Adults

Led by Riverside University Health System Medical Center · Updated on 2025-11-10

176

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Hospitalized for at least 72 hours
  • Receiving systemic antibiotics for at least 72 hours during hospitalization
  • Have at least two of the following risk factors: age 65 or older, previous long-term care residence, proton pump inhibitor use, inflammatory bowel disease, immunocompromised state, end stage renal disease, diabetes mellitus, use of catecholamines (norepinephrine ≥ 5 mcg/min), hospitalization within 30 days prior with systemic antibiotic use
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Currently incarcerated individuals
  • Unable to provide informed consent
  • Not expected to survive ICU stay or likely to receive palliative or hospice care
  • Receiving concurrent treatment with metronidazole (except one-time empiric use)
  • Receiving concurrent probiotics
  • Allergic or contraindicated to enteral vancomycin
  • History of Clostridioides difficile infection within past 90 days
  • Suspected active Clostridioides difficile infection prior to inclusion
  • Expected antibiotic treatment exceeding 14 days during hospitalization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Up to 19 days depending on antibiotic duration (systemic antibiotic for at least 72 hours plus up to 5 days post-antibiotic)

Participants receive oral vancomycin 125 mg daily or a matching placebo daily during systemic antibiotic exposure and for up to five days after the last antibiotic dose.

Visits every 3 days until hospital discharge

Follow-up

Duration - Up to 4 months

Participants are monitored for clinical outcomes including incidence of Clostridioides difficile infection and vancomycin-resistant Enterococcus colonization after treatment ends.

Follow-up visits or assessments up to 4 months post-treatment

Trial Site Locations

Total: 1 location

1

Riverside University Health System

Moreno Valley, California, United States, 92373

Actively Recruiting

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Research Team

S

Suman Thapamagar, MD

B

Brian Phan, PharmD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study.

Shanshan Zhang, Sarah Palazuelos-Munoz, Evelyn M Balsells...

https://pubmed.ncbi.nlm.nih.gov/27562241

Clostridium difficile infection: toxins and non-toxin virulence factors, and their contributions to disease establishment and host response.

Gayatri Vedantam, Andrew Clark, Michele Chu...

https://pubmed.ncbi.nlm.nih.gov/22555464

The Hospital Environment as a Potential Source for Clostridioides difficile Transmission Based on Spore Detection Surveys Conducted at Paediatric Oncology and Gastroenterology Units.

Ewelina Lemiech-Mirowska, Michał Michałkiewicz, Aleksandra Sierocka...

https://pubmed.ncbi.nlm.nih.gov/36674344