Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

University of Maryland Baltimore (UMB)

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: Vancomycin Resistance Enterococcus Faecium; Clostridioides Difficile

Treatments: Drug: Vancomycin (POC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07221708

HP-00113868

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Oral Vancomycin

Experimental group

Description:

The oral vancomycin treatment group will receive oral vancomycin 125 mg twice daily for the duration of the concomitant antibiotic plus two additional days.

Treatment:

Drug: Vancomycin (POC)

No Oral Vancomycin

No Intervention group

Description:

The no oral vancomycin control group will receive the current standard of care treatment which is an antibiotic with no oral vancomycin.