NCT07221370 · Riverside University Health System Medical Center
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
What this study is about
The goal of this clinical trial is to determine if taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Vancomycin 125mg
Vancomycin 125 mg orally daily
DRUG
Placebo
Syrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator.
Primary outcome measures
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).
Time frame: up to 4 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must meet all 3 criteria:
- 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
- Age ≥ 65 years
- Previous residence in long-term care facility
- Previous proton pump inhibitor use (chronic or as needed)
- Inflammatory bowel disease
- Immunocompromised state (HIV/AIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)
- End stage renal disease (ESRD)
- Diabetes mellitus
- Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg/min)
- Hospitalized ≤ 30 days prior to the index hospitalization.
- Received systemic antibiotics during that prior hospitalization.
Exclusion 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
- Receiving concurrent treatment with metronidazole for any indication
- One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
- Receiving concurrent probiotics
- Allergic reaction or had a contraindication for use of enteral vancomycin
- History of prior CDI within the past 90 days of randomization
- Had suspected active CDI prior to inclusion
- Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization
Where
- Moreno Valley, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations