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

Study identifier:D3720C00001

ClinicalTrials.gov identifier:NCT01499277

EudraCT identifier:2011-004013-16

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Medical condition

Complicated skin and soft tissue infection

Phase

Phase 3

Healthy volunteers

No

Study drug

Ceftaroline fosamil, Vancomycin, Aztreonam

Sex

All

Actual Enrollment

802

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 May 2012
Primary Completion Date: 01 Jun 2014
Study Completion Date: 01 Jan 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria