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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 is a Phase 3 study that has completed, run by Wockhardt. The registered enrollment target is 530 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04979806
The ClinicalTrials.gov registry entry for NCT04979806 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Meropenem is the first listed.
NCT04979806 reports 0 study locations.
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.
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