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NCT01978938 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
A Phase 3 study, sponsored by Tetraphase Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 908
- Enrollment target
NCT01978938: Completed Phase 3 study, sponsored by Tetraphase Pharmaceuticals.
NCT01978938 is a Phase 3 study that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 908 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01978938, a Phase 3 study, has completed, sponsored by Tetraphase Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 908 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
Primary Outcome
This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure
Interventions
- DRUG Eravacycline
- DRUG Levofloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 908 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2015-08-21 |
| Phase | Phase 3 |
What the finished NCT01978938 record still lists
NCT01978938 is an interventional study that assigns participants to a tested intervention. The registered 908 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which Eravacycline is the first listed.
NCT01978938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01978938 about?
NCT01978938 is a clinical study titled "Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections". This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).
What is the current status of trial NCT01978938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 908 participants. The study started on 2014-10-06. Estimated completion is 2015-08-21.
What interventions are being tested in trial NCT01978938?
The interventions under investigation include: Eravacycline (DRUG), Levofloxacin (DRUG).
Who is sponsoring clinical trial NCT01978938?
This trial is sponsored by Tetraphase Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01978938's enrollment target sits among peer trials
908 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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