Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

January 6, 2026 updated by: Jeffrey Marshall, University of Maryland, Baltimore

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin in Patients Treated With Systemic Antibiotic Therapy in a Community Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study is being conducted to evaluate the feasibility of prescribing oral vancomycin in preventing CDI in patients who are receiving concomitant systemic antibiotics.

There are two groups: one group will receive oral vancomycin 125 mg twice daily for the duration of systemic antibiotic use plus two additional days; the other group will receive the current standard of care which is no oral vancomycin. The investigators aim to collect data from 100 patients in each group for a total of 200 patients.

Eligible participants will be randomized in a 1:1 ratio to receive either oral vancomycin or no oral vancomycin. A computer-generated randomization sequence has been created using block randomization with variable block sizes (4, 6, 8) to maintain group balance and reduce predictability.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • University of Maryland Baltimore Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Marshall, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 65 years or older
  • Receive systemic antibiotics in the last 90 days
  • Hospitalized anywhere in the last 90 days
  • History of C diff colonization without history of C diff colitis (infection)
  • Provide informed consent
  • Read and understand the English language
  • Not current taking probiotics
  • Lack of allergy or contraindications to receive vancomycin
  • Ability to take oral medications
  • Not receiving medications that can be used to treat or prevent C diff

Exclusion Criteria:

  • Age 64 years or younger
  • Has not received systemic antibiotics in the last 90 days
  • Has not been hospitalized in the last 90 days
  • History of C diff colonization with a history of C diff colitis (infection)
  • Not provided informed consent
  • Cannot read and understand the English language
  • Currently receiving probiotics
  • Allergy or contraindications to receive vancomycin
  • Unable to take oral medications
  • Receiving medications that can be used to treat or prevent C diff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Vancomycin (POC)
A dosage of oral vancomycin 125 mg will be given 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Hospitalization duration and through 90 days post hospitalization discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who develop vancomycin resistant enterococcus
Time Frame: At start of study participation (baseline) and at completion of antibiotics (up to four weeks).
Perirectal swabs to detect vancomycin-resistant Enterococcus (VRE) will be performed at the time of study inclusion and repeated at discharge. The investigators will use this data to evaluate acquisition of resistance following exposure to vancomycin.
At start of study participation (baseline) and at completion of antibiotics (up to four weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

University of Maryland, Baltimore Washington Medical Center

Investigators

  • Principal Investigator: Jeffrey Marshall, MD, University of Maryland, Baltimore Washington Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 17, 2025

First Submitted That Met QC Criteria

October 27, 2025

First Posted (Estimated)

October 28, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00113868

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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