Clostridioides Difficile, Vancomycin Resistance Enterococcus Faecium
Conditions
Keywords
Clostridioides Difficile, Vancomycin Resistance Enterococcus faecium, C Diff, VRE, Vancomycin, C Diff Infection
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.
Detailed description
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.
Interventions
DRUGVancomycin (POC)
A dosage of oral vancomycin 125 mg will be given twice daily for the duration of the concomitant antibiotic plus two additional days
Sponsors
University of Maryland, Baltimore
University of Maryland, Baltimore Washington Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who develop vancomycin resistant enterococcus | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Marshall, MD
University of Maryland, Baltimore Washington Medical Center
Outcome results
None listed