Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: AstraZeneca
• Treatments: Aztreonam; Cefazolin; Ceftaroline fosamil; Cephalexin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Linezolid; Vancomycin

Criteria

Inclusion Criteria:

• Male or female, 2 months to < 18 years old.

• Presence of ABSSSI warranting initial hospitalization.

• Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention

Exclusion Criteria:

• Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial

• Uncomplicated skin and soft tissue infections

• More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.

• Requirement for any concomitant systemic antimicrobial therapy

• History of seizures, excluding well-documented febrile seizure of childhood.

• Clinical signs or suspicion of meningitis