A Phase 2/3 interventional study of Vancomycin (POC) in Clostridioides Difficile and Vancomycin Resistance Enterococcus Faecium, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by University of Maryland, Baltimore · Phase 2/3, Interventional, and Prevention
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.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
Browse Clostridium Infections studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
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)
The no oral vancomycin control group will receive the current standard of care treatment which is an antibiotic with no oral vancomycin.
A dosage of oral vancomycin 125 mg will be given twice daily for the duration of the concomitant antibiotic plus two additional days
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
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).
Plan to share: No
This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore