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NCT Number: NCT07221708

Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

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.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Emel

CONTACT

[email protected]

410-553-8048

Loren Daoud, MPH

CONTACT

[email protected]

410-787-4474

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • University of Maryland, Baltimore Washington Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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