University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061, United States
Location contact
Jeffrey Marshall, MD
PRINCIPAL_INVESTIGATOR
Jennifer Emel
CONTACT
Loren Daoud, MPH
CONTACT
NCT Number: NCT07221708
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.
Trial opening soon.
Get Notified65 year–100 year
All sexes
Interventional
Phase 2 / Phase 3
Glen Burnie, Maryland, 21061, United States
Jeffrey Marshall, MD
PRINCIPAL_INVESTIGATOR
Jennifer Emel
CONTACT
Loren Daoud, MPH
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A dosage of oral vancomycin 125 mg will be given twice daily for the duration of the concomitant antibiotic plus two additional days
Time frame: Hospitalization duration and through 90 days post hospitalization discharge
Time frame: At start of study participation (baseline) and at completion of antibiotics (up to four weeks).
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.
Contact information is provided by the study sponsor or research team.
Jennifer Emel
CONTACT
Loren Daoud, MPH
CONTACT
University of Maryland, Baltimore
Other
Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin in Patients Treated With Systemic Antibiotic Therapy in a Community Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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