Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin
NCT ID: NCT07221708
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2026-03-01
2027-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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 Oral Vancomycin
The no oral vancomycin control group will receive the current standard of care treatment which is an antibiotic with no oral vancomycin.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
100 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore Washington Medical Center
UNKNOWN
University of Maryland, Baltimore
OTHER
Responsible Party
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Jeffrey Marshall
Associate Chief Medical Officer and VP of Quality and Patient Safety
Principal Investigators
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Jeffrey Marshall, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore Washington Medical Center
Locations
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University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ganetsky A, Han JH, Hughes ME, Babushok DV, Frey NV, Gill SI, Hexner EO, Loren AW, Luger SM, Mangan JK, Martin ME, Smith J, Freyer CW, Gilmar C, Schuster M, Stadtmauer EA, Porter DL. Oral Vancomycin Prophylaxis Is Highly Effective in Preventing Clostridium difficile Infection in Allogeneic Hematopoietic Cell Transplant Recipients. Clin Infect Dis. 2019 May 30;68(12):2003-2009. doi: 10.1093/cid/ciy822.
Papic N, Maric LS, Vince A. Efficacy of oral vancomycin in primary prevention of Clostridium Difficile infection in elderly patients treated with systemic antibiotic therapy. Infect Dis (Lond). 2018 Jun;50(6):483-486. doi: 10.1080/23744235.2018.1425551. Epub 2018 Jan 11. No abstract available.
Maraolo AE, Mazzitelli M, Zappulo E, Scotto R, Granata G, Andini R, Durante-Mangoni E, Petrosillo N, Gentile I. Oral Vancomycin Prophylaxis for Primary and Secondary Prevention of Clostridioides difficile Infection in Patients Treated with Systemic Antibiotic Therapy: A Systematic Review, Meta-Analysis and Trial Sequential Analysis. Antibiotics (Basel). 2022 Jan 30;11(2):183. doi: 10.3390/antibiotics11020183.
Tariq R, Laguio-Vila M, Tahir MW, Orenstein R, Pardi DS, Khanna S. Efficacy of oral vancomycin prophylaxis for prevention of Clostridioides difficile infection: a systematic review and meta-analysis. Therap Adv Gastroenterol. 2021 Feb 23;14:1756284821994046. doi: 10.1177/1756284821994046. eCollection 2021.
Johnson SW, Brown SV, Priest DH. Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure. Clin Infect Dis. 2020 Aug 22;71(5):1133-1139. doi: 10.1093/cid/ciz966.
Other Identifiers
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HP-00113868
Identifier Type: -
Identifier Source: org_study_id
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