Phase 4
N=33
Impact of Oral Antibiotic Treatment on C. Difficile
C. Difficile · Diarrhea · Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT02057198 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. — 56; 33; 149; 7 Colony forming units (CFUs) — p=0.52
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fidaxomicin (Drug); Metronidazole (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. |
56; 33; 149; 7; 53; 24 | 0.52 |
| SECONDARY Total Environmental Contamination According to Antibiotic Treatment Group |
13.4; 18.6; 7.6 | <0.001 sig |
| SECONDARY Molecular Relatedness of Isolates |
68.1; 80.0; 77.8 | 0.99 |
| SECONDARY C. Difficile Shedding in Stool Over Time |
815940; 2233564; 35340; 72200; 1200; 400 | 0.05 |
| SECONDARY Count of Stool Specimens From Patients That Are Positive for C. Difficile |
20; 21; 17; 6; 3; 2 | — |
| SECONDARY Percentage of Stool Specimens From Patients That Are Positive for C. Difficile |
100; 95.5; 85; 60; 75; 33 | 0.48 |
Summary
The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective, randomized, microbiologic and molecular, study of environmental contamination from patients with proven C. difficile associated diarrhea (CDAD).
Eligibility Criteria
Inclusion Criteria
- adult patients with microbiology-proven CDAD
- provides informed consent
- eligible to receive oral antibiotic therapy
Exclusion Criteria
- prisoners
- pregnant women
- children <18 years
- patients who have contra-indications for perianal swabs, those who has medical conditions that would invalidate the results of the swabs
- patients requiring intravenous therapy for treatment of CDAD
- patients who do not consent and those who withdraw consent
Data sourced from ClinicalTrials.gov (NCT02057198). 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.