A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of a Single Dose of Intravenous Ceftazidime NXL104 (3000/2000 mg) or Ceftaroline Fosamil NXL104 (1500/2000 mg), Compared With Placebo, Using Moxifloxacin (Avelox) as a Positive Control, in Healthy Male Volunteers.
Phase of Trial: Phase I
Latest Information Update: 04 Sep 2017
At a glance
- Drugs Avibactam/ceftaroline fosamil (Primary) ; Avibactam/ceftazidime (Primary) ; Moxifloxacin
- Indications Bacterial infections; Intra-abdominal infections; Nosocomial pneumonia; Urinary tract infections
- Focus Adverse reactions
- Sponsors AstraZeneca
- 28 Jun 2016 According to AstraZeneca media release, the European Commission has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.
- 03 Apr 2012 Primary endpoint 'QT-interval' has been met.
- 03 Apr 2012 Results presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History