Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Pneumonia; Infections

Treatments: Drug: IV Ceftriaxone and Vancomycin; Drug: Ceftaroline fosamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669980

P903-24

Details and patient eligibility

About

This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.

Full description

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Enrollment: 40 patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of CABP warranting 3 days of initial hospitalization
• Confirmed presence of indicators of complicated CABP

Exclusion criteria

• Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
• Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
• Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
• Non-infectious causes of pulmonary infiltrates

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Ceftaroline fosamil

Experimental group

Treatment:

Drug: Ceftaroline fosamil

IV Ceftriaxone and Vancomycin

Active Comparator group

Treatment:

Drug: IV Ceftriaxone and Vancomycin