The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are:
* Does oral vancomycin lower the rate of C.diff infection in high-risk patients? * Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital.
Participants will:
* Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days. * When discharged from the hospital, participants will continue to take the study medication in the event he/she did not complete the intended course of the study medication while in the hospital. * Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus) * After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.
Adults aged 18 years and older.
Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
Admitted ≥ 72 hours into their index hospitalization.
And must meet 2 additional of the following high-risk criteria
Pregnant or breastfeeding women
Currently incarcerated individuals
Individual or legal representative whose informed consent cannot be obtained
Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
Parallel
Vancomycin 125mg
DrugVancomycin 125 mg orally daily
Placebo
DrugSyrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator.
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).
Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction \[PCR\] and stool toxin test) \> 72 hours into hospitalization.
Incidence of Vancomycin Resistance Enterococcus (VRE) colonization in stool sample.
The rate of emergence of VRE will be tested as a part of safety outcome. All enrolled subject into the study will have stool/rectal swab tested for VRE at the time of enrollment and end of the study/early termination.
Rate community onset healthcare facility-associated CDI.
Community-onset healthcare facility-associated CDI (CO-HFCA-CDI) will be assessed via telephonic surveys with the subjects 30- and 90-day post-discharge. CO-HFCA-CDI is defined as follows: subject's verbal confirmation of unexplained and new-onset ≥3 unformed stools in a 24-hour period since being discharged, subject seeking medical care for loose stools, and subject being diagnosed with CDI by a medical provider.
Time to Clostridioides difficile infection in symptomatic patients
Time to Clostridioides difficile infection in symptomatic patients
Clostridioides difficile colonization at discharge (PCR and toxin)
Clostridioides difficile colonization at discharge (PCR and toxin)
Stratification of study populaton based on B1/NAP1/027 gene at baseline
Number of participants with B1/NAP1/027 gene compared to number of participants without B1/NAP1/027 gene at baseline with positive primary and secondary outcomes.
Stratification of study population based on age
Number of participants with age \<65 as compared to number of participants with age \>=65 with positive primary and secondary outcomes.
Stratification of study population based on use of vasopressor
Number of participants with use of vasopressor compared to number of participants without use of vasopressor with positive primary and secondary outcomes.
Severe IgE mediated type I hypersensitivity reactions
Severe IgE mediated type I hypersensitivity reactions between 2 grouips
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