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NCT04979806 · ClinicalTrials.gov registry record · Phase 3
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Phase 3 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT04979806: Completed Phase 3 study, sponsored by Wockhardt.
NCT04979806 is a Phase 3 study that has completed, run by Wockhardt. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04979806, a Phase 3 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
Primary Outcome
Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Interventions
- DRUG Meropenem
- DRUG Cefepime-zidebactam (FEP-ZID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2022-08-28 |
| Est. Completion | 2024-11-25 |
| Phase | Phase 3 |
What the finished NCT04979806 record still lists
NCT04979806 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Meropenem is the first listed.
NCT04979806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04979806 about?
NCT04979806 is a clinical study titled "Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)". This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI ...
What is the current status of trial NCT04979806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2022-08-28. Estimated completion is 2024-11-25.
What interventions are being tested in trial NCT04979806?
The interventions under investigation include: Meropenem (DRUG), Cefepime-zidebactam (FEP-ZID) (DRUG).
Who is sponsoring clinical trial NCT04979806?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04979806's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 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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