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

Forest Laboratories

Status and phase

Completed

Phase 3

Phase 2

Conditions

Infections, Pediatrics

Treatments

Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam

Drug: Cephalexin or Clindamycin or Linezolid

Drug: Ceftaroline fosamil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01400867

P903-23

Details and patient eligibility

About

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.

Full description

To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

Enrollment

163 patients

Sex

All

Ages

2 months to 17 years old

Volunteers

No Healthy Volunteers

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