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NCT02753946 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
A Phase 2 study, sponsored by Nabriva Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 465
- Enrollment target
NCT02753946: Completed Phase 2 study, sponsored by Nabriva Therapeutics.
NCT02753946 is a Phase 2 study that has completed, run by Nabriva Therapeutics. The registered enrollment target is 465 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02753946, a Phase 2 study, has completed, sponsored by Nabriva Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 465 participants
- Enrollment target
Study Summary
The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).
Primary Outcome
Clinical cure (resolution or significant improvement in signs and symptoms) and microbiologic eradication (baseline pathogen) in m-MITT population
Interventions
- DRUG Piperacillin-tazobactam
- DRUG ZTI-01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-05-30 |
| Phase | Phase 2 |
What the finished NCT02753946 record still lists
NCT02753946 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher).
The record links to 0 conditions, and to 2 interventions - of which Piperacillin-tazobactam is the first listed.
NCT02753946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02753946 about?
NCT02753946 is a clinical study titled "Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections". The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acut...
What is the current status of trial NCT02753946?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 465 participants. The study started on 2016-04. Estimated completion is 2017-05-30.
What interventions are being tested in trial NCT02753946?
The interventions under investigation include: Piperacillin-tazobactam (DRUG), ZTI-01 (DRUG).
Who is sponsoring clinical trial NCT02753946?
This trial is sponsored by Nabriva Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02753946's enrollment target sits among peer trials
465 80th of 2000 higher than 1,920 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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