WHO ICTRP trial
A clinical trial to evaluate the safety and efficacy of Cefepime-Tazobactam in…
EUCTR2017-005117-31-CZ · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2017-005117-31-CZ |
|---|---|
| Public title | A clinical trial to evaluate the safety and efficacy of Cefepime-Tazobactam in comparison to meropenem in hospitalized patients with complicated urinary tract infections or acute pyelonephritis |
| Scientific title | A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults - Phase III study of… |
| Primary sponsor | Wockhardt Bio AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Belarus;Czech Republic;Mexico;Poland;Ukraine;Romania;Lithuania;Peru;Bulgaria;Latvia;India |
| Conditions | Complicated urinary tract infection or acute pyelonephritis MedDRA version: 20.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level… |
| Interventions | Product Name: cefepime-tazobactam Product Code: WCK 4282 (FEP-TAZ) Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CEFEPIME HYDROCHLORIDE CAS Number: 123171-59-5 Concentration unit: g gram(s) Concentration type… |
| Registration date | Jun 14, 2018 |
| Target size | 1004 |
| Secondary IDs | W-4282-301;127025 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: