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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Bacterial Infections

Treatments: Drug: ceftaroline; Drug: Placebo; Drug: vancomycin plus aztreonam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423657

P903-07

Details and patient eligibility

About

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

Full description

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Enrollment: 680 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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680 participants in 2 patient groups

Ceftaroline fosamil for Injection

Experimental group

Description:

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Treatment:

Drug: Placebo

Drug: ceftaroline

IV Vancomycin plus IV Aztreonam

Active Comparator group

Description:

Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

Treatment:

Drug: vancomycin plus aztreonam