Trial Profile
Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of ZTI-01 vs Piperacillin/Tazobactam in the Treatment of cUTI/AP Infection in Hospitalized Adults
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 31 Aug 2022
Price :
$35
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At a glance
- Drugs Fosfomycin (Primary) ; Piperacillin/tazobactam
- Indications Pyelonephritis; Urinary tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ZEUS
- Sponsors Zavante Therapeutics
- 29 Aug 2022 Results of an analysis assessed the Desirability of outcome ranking (DOOR) approach application to Improving traditional registrational trial endpoints applied to three registrational drug trials (ZEUS, APEKS-cUTI, and DORI-05) published in the Clinical Infectious Diseases
- 05 Apr 2021 According to a Nabriva Therapeutics media release, this extension provides the Agency adequate time to assess the application of the recently issued guidance entitled "Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19" to the CONTEPO re-submission.
- 05 Apr 2021 According to a Nabriva Therapeutics media release, the Food and Drug Administration (FDA) granted Nabriva an extension for the re-submission of the New Drug Application for CONTEPO with the FDA to June 19, 2022 due to the ongoing COVID-related travel restrictions that have impacted the Agency's ability to conduct onsite inspections of foreign manufacturing facilities.