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NCT02057198 · ClinicalTrials.gov registry record · Phase 4
Impact of Oral Antibiotic Treatment on C. Difficile
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT02057198: Completed Phase 4 study, sponsored by Duke University.
NCT02057198 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02057198, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study 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).
Primary Outcome
Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of \~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each t
Interventions
- DRUG Vancomycin
- DRUG Metronidazole
- DRUG Fidaxomicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-06-10 |
| Est. Completion | 2017-06-27 |
| Phase | Phase 4 |
What the finished NCT02057198 record still lists
NCT02057198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Vancomycin is the first listed.
NCT02057198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02057198 about?
NCT02057198 is a clinical study titled "Impact of Oral Antibiotic Treatment on C. Difficile". 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 mole...
What is the current status of trial NCT02057198?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2014-06-10. Estimated completion is 2017-06-27.
What interventions are being tested in trial NCT02057198?
The interventions under investigation include: Vancomycin (DRUG), Metronidazole (DRUG), Fidaxomicin (DRUG).
Who is sponsoring clinical trial NCT02057198?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02057198's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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