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NCT02692651 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
A Phase 4 study of Clostridium Difficile Infection (CDI), sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 144
- Enrollment target
- 2
- Study locations
NCT02692651 is a Phase 4 study of Clostridium Difficile Infection (CDI) that has completed, run by University of Michigan. The registered enrollment target is 144 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT02692651, a Phase 4 study of Clostridium Difficile Infection (CDI), has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 144 participants
- Enrollment target
- 2
- Study locations
Study Summary
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA. We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
Conditions Studied
Interventions
- DRUG Vancomycin
- DRUG Fidaxomicin
Study Locations (2)
Michigan
- University of Michigan - Ann Arbor
- St. Joseph Mercy Hospital - Ypsilanti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2021-06-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02692651
The ClinicalTrials.gov registry entry for NCT02692651 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Difficile Infection (CDI) appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin is the first listed.
NCT02692651 reports 2 study locations spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT02692651 about?
NCT02692651 is a clinical study titled "A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections". Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians rema...
What is the current status of trial NCT02692651?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2017-05-01. Estimated completion is 2021-06-23.
What conditions does trial NCT02692651 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection (CDI).
What interventions are being tested in trial NCT02692651?
The interventions under investigation include: Vancomycin (DRUG), Fidaxomicin (DRUG).
Who is sponsoring clinical trial NCT02692651?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02692651 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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