Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Bacterial Infection

Treatments: Drug: ceftaroline; Drug: linezolid; Drug: Aztreonam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633152

P903-19

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 and skin structure infections in adults.

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Complicated skin and skin structure infection (cSSSI)
• Require initial hospitalization, or treatment in an emergency room or urgent care setting

Exclusion criteria

• Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
• Concomitant use of adrenergic or serotonergic agent
• Uncomplicated skin and skin structure infection
• Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
• More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
• Known or suspected endocarditis, osteomyelitis, or septic arthritis
• Severely impaired renal function
• Evidence of significant hepatic, hematologic, or immunologic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Ceftaroline

Experimental group

Description:

Intramuscular every 12 hours

Treatment:

Drug: ceftaroline

linezolid plus optional aztreonam

Active Comparator group

Description:

Intravenous every 12 hours

Treatment:

Drug: Aztreonam

Drug: linezolid