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NCT03032510 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections
A Phase 3 study, sponsored by Tetraphase Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,205
- Enrollment target
NCT03032510: Completed Phase 3 study, sponsored by Tetraphase Pharmaceuticals.
NCT03032510 is a Phase 3 study that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 1,205 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03032510, a Phase 3 study, has completed, sponsored by Tetraphase Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,205 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).
Primary Outcome
This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem 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 Placebo
- DRUG Eravacycline
- DRUG Levofloxacin
- DRUG Ertapenem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,205 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-01 |
| Phase | Phase 3 |
What the finished NCT03032510 record still lists
NCT03032510 is an interventional study that assigns participants to a tested intervention. Its 1,205 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03032510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03032510 about?
NCT03032510 is a clinical study titled "Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections". The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of eravacycline compared to ertapenem in treating participants with complicated urinary tract infections (cUTI).
What is the current status of trial NCT03032510?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,205 participants. The study started on 2017-01. Estimated completion is 2018-01.
What interventions are being tested in trial NCT03032510?
The interventions under investigation include: Placebo (DRUG), Eravacycline (DRUG), Levofloxacin (DRUG), Ertapenem (DRUG).
Who is sponsoring clinical trial NCT03032510?
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 NCT03032510's enrollment target sits among peer trials
1,205 219th of 2000 higher than 1,781 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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