Overview

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Status:
Completed

Trial end date:
2007-12-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Forest Laboratories

Treatments:

Aztreonam
Ceftaroline fosamil
Cephalosporins
Vancomycin

Criteria

Inclusion Criteria:

- Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires
significant surgical intervention, or cellulitis or abscess on lower extremity which
occurs in subjects with diabetes mellitus or well-documented peripheral vascular
disease.

Exclusion Criteria:

- Prior treatment of current complicated skin and skin structure infection (cSSSI) with
an antimicrobial.

- Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior
isolation of an organism with in vitro resistance to vancomycin or aztreonam.