Phase 4
N=674
Screening to Prophylax Against Clostridium Difficile Infection -
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT02996487 ↗Enrolled (actual)
674
Serious AEs
29.6%
Results posted
Aug 2024
Primary outcome: Primary: The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vancomycin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. |
0; 0 | — |
| SECONDARY The Severity of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY The Outcome of CDI in Patients Receiving Vancomycin Prophylaxis vs. Placebo. |
0; 0 | — |
| SECONDARY The Prevalence of Toxigenic C. Difficile Colonization Among the Inpatient Population Treated With High-risk Antibiotics Based on C. Difficile PCR. |
5; 5 | — |
| SECONDARY The Incidence of CDI in Patients Initiated on High Risk Antibiotics Who Are Not Colonized With Toxigenic C. Difficile. |
4 | — |
Summary
The goal of this study is to evaluate whether using vancomycin orally can prevent CDI in patients who are colonized with C. difficile who are admitted to the hospital and need antibiotics for another infection.
Eligibility Criteria
Inclusion Criteria
- Expected duration of admission sufficient to complete screening and enrollment
- Age ≥18
- Able to give informed consent
- Initiated on one of the following antibiotics within the prior 72 hours with an expected duration of at least 72 hours from enrollment: clindamycin, ampicillin, ampicillin/sulbactam, amoxicillin, amoxicillin/clavulanate, moxifloxacin, levofloxacin, piperacillin/tazobactam, or any cephalosporin
- Maximum expected duration of antibiotics 8 weeks
- Able to take oral study medications
- Able to provide a stool sample during hospitalization or within 3 days of discharge
- Reasonably expected to be able to complete follow up
Exclusion Criteria
- Chron's disease, ulcerative colitis, celiac disease, or other chronic diarrheal illness
- CDI within prior 90 days
- Currently on metronidazole, oral vancomycin, rifaximin, fidaxomicin, or any other antibiotic active against C. difficile
- Current diarrhea
- Current ileostomy, colostomy or other form of surgically disconnected gut such that oral therapy would not be expected to reach the entire lumen of the gut
- Pregnancy or breast feeding (determined prior to randomization)
- Travel to an area of endemic diarrheal illness within the last 30 days
- Life expectancy of less than 60 days
- Known allergy to vancomycin
- Participation with other research trials that could impact the results of this trial within the last 30 days
- Previously enrolled in this study
Data sourced from ClinicalTrials.gov (NCT02996487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.