Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

Part of paid clinical trials in Glen Burnie, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07221708
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Clostridioides Difficile
  • Vancomycin Resistance Enterococcus Faecium

Eligibility Criteria

Sex
ALL
Age
65 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Vancomycin (POC) — DRUG
    A dosage of oral vancomycin 125 mg will be given twice daily for the duration of the concomitant antibiotic plus two additional days

Study Details

The purpose of this study is to evaluate the ability of oral vancomycin in preventing Clostridioides difficile infection (CDI) in patients that are simultaneously receiving antibiotics. Participants in this study will be placed randomly into two groups. The oral vancomycin treatment group will receive oral vancomycin two times per day simultaneously with an antibiotic plus two additional days. The no oral vancomycin control group will receive the current standard of care, which is an antibiotic and no oral vancomycin. Participation in this study will last approximately 3 months.

Key Dates

Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Oral Vancomycin
    The oral vancomycin treatment group will receive oral vancomycin 125 mg twice daily for the duration of the concomitant antibiotic plus two additional days.
  • No Intervention: No Oral Vancomycin
    The no oral vancomycin control group will receive the current standard of care treatment which is an antibiotic with no oral vancomycin.

Primary Outcome Measure

Number of participants who develop C diff after receiving oral vancomycin plus another antibiotic at the same time versus participants who do not receive oral vancomycin [ Time Frame: Hospitalization duration and through 90 days post hospitalization discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore Washington Medical CenterGlen BurnieMaryland21061
Loren Daoud, MPH
[email protected]
410-787-4474
Jennifer Emel
[email protected]
410-553-8048
Jeffrey Marshall, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland Baltimore Washington Medical Center· Glen Burnie, MD