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

Study identifier:D3720C00001sub

ClinicalTrials.gov identifier:NCT02202135

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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) vs 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

4

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Jun 2014
Primary Completion Date: 01 Jan 2015
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 Mar 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria