Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

Phase 3Not Yet RecruitingNCT07221708

University of Maryland, Baltimore200 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Clostridioides Difficile

Eligibility

Sex: ALLMin age: 65 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Number of participants who develop vancomycin resistant enterococcus

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.

Time frame: At start of study participation (baseline) and at completion of antibiotics (up to four weeks).