Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Summary

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Timeline

Start

2014-06

Primary completion

2015-01

Completion

2015-01

Outcome

Met primary endpoint

Stopped (Enrollment): “Overall study status is changed to "Terminated" due to low enrollment”

paper Clinical cure rates at TOC demonstrated non-inferiority of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in the MITT and CE populations: PMID 27585969 ↗

paper 396/506 (78.3%) versus 202/255 (79.2%) patients (difference -1.0%, 95% CI -6.9, 5.4) PMID 27585969 ↗

Publications

• Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aztreonam	Small molecule	1 g	Intravenous
Subject	Ceftaroline fosamil	Other / unclassified	600 mg	Intravenous
Comparator	Vancomycin	Other / unclassified	15 mg/kg	Intravenous

Indications

No indication recorded.