Phase 4
N=51
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Clostridium Difficile Infection · Prophylaxis · Vancomycin
Bottom Line
View on ClinicalTrials.gov: NCT02951702 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Clostridium Difficile Infection Occurrence — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vancomycin Oral (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clostridium Difficile Infection Occurrence |
2; 0 | — |
| SECONDARY Time to Clostridium Difficile Infection Occurence |
2; 0 | — |
| SECONDARY Clostridium Difficile Infection Severity |
1; 0; 1; 0 | — |
Summary
The purpose of this study is to determine if oral vancomycin used as primary Clostridium difficile prophylaxis can reduce the incidence of this infection in high-risk patients.
Eligibility Criteria
Inclusion Criteria
- "High-risk" patients defined as: age older than 65, on gastric acid suppression, and select antibiotics
- Gastric acid suppression includes proton pump inhibitors and histamine-2 receptor antagonists
- Selected antibiotics include fluoroquinolone (ciprofloxacin, levofloxacin), clindamycin, a 3rd or 4th generation cephalosporin, a broad-spectrum aminopenicillin (ampicillin-sulbactam, piperacillin-tazobactam), or a carbapenem
Exclusion Criteria
- Failure to meet all three requirements for "high risk"
- Vancomycin allergy
- Active clostridium difficile infection prior to inclusion
- Prophylactic oral vancomycin prior to study inclusion (i.e. prolonged vancomycin taper)
- Receipt of medications that also treat Clostridium difficile (metronidazole, rifaximin, fidaxomicin)
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02951702). 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.