Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

NCT07221708 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HP-00113868
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vancomycin Resistance Enterococcus Faecium; Clostridioides Difficile

Keywords

Clostridioides Difficile; Vancomycin Resistance Enterococcus faecium; C Diff; VRE; Vancomycin; C Diff Infection

Outcome Measures

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

  Hospitalization duration and through 90 days post hospitalization discharge

Secondary Outcomes (1)

• Number of participants who develop vancomycin resistant enterococcus

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

Study Arms (2)

Oral Vancomycin

EXPERIMENTAL

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)

No Oral Vancomycin

NO INTERVENTION

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

Interventions

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

Oral Vancomycin

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore Washington Medical Center: collaborator
• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

Related Publications (5)

• 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.

  PMID: 30256954 BACKGROUND

• 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.

  PMID: 29323607 BACKGROUND

• 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.

  PMID: 35203786 BACKGROUND

• 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. Ther Adv Gastroenterol. 2021 Feb 23;14:1756284821994046. doi: 10.1177/1756284821994046. eCollection 2021.

  PMID: 33747124 BACKGROUND

• 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.

  PMID: 31560051 BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey Marshall, MD

  University of Maryland, Baltimore Washington Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loren Daoud, MPH

CONTACT

410-787-4474; loren.daoud@umm.edu

Jennifer Emel

CONTACT

410-553-8048; Jennifer.Emel@umm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Medical Officer and VP of Quality and Patient Safety

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 28, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)