A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections.
Phase of Trial: Phase III
Latest Information Update: 15 Nov 2016
At a glance
- Drugs Doripenem (Primary) ; Cefepime
- Indications Bacterial infections; Urinary tract infections
- Focus Registrational; Therapeutic Use
- Sponsors Janssen Research & Development
- 01 Jul 2014 The primary endpoint has been changed from adverse events to number of participants with clinical cure rate at test of cure visit, according to ClinicalTrials.gov record.
- 20 Mar 2012 Additional lead trial centre identified as reported by ClinicalTrials.gov.
- 03 Nov 2011 Planned End Date changed from 1 Mar 2013 to 1 Apr 2014 as reported by ClinicalTrials.gov.