A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults.
Phase of Trial: Phase III
Latest Information Update: 08 Sep 2017
At a glance
- Drugs Avibactam/ceftazidime (Primary) ; Ciprofloxacin; Cotrimoxazole; Doripenem
- Indications Gram-negative infections; Pyelonephritis; Urinary tract infections
- Focus Registrational; Therapeutic Use
- Acronyms RECAPTURE-2
- Sponsors AstraZeneca
- 30 Jan 2017 Results from complicated urinary tract infections (cUTI) patients published in an AstraZeneca Media Release
- 30 Jan 2017 According to AstraZeneca media release, the U.S. Food and Drug Administration (FDA) has approved supplemental New Drug Application (sNDA) to update the label for AVYCAZ (ceftazidime and avibactam) to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms with clinical data from RECAPTURE and REPRISE trials.
- 14 Jan 2017 Results assessing the In-vitro activity of ceftazidime/avibactam against urinary isolates from patients in two phase III studies (RECAPTURE-1 and RECAPTURE-2; n=1033) published in the Journal of Antimicrobial Chemotherapy