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

Forest Laboratories

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infections; Community Acquired Pneumonia

Treatments: Drug: amoxicillin clavulanate; Drug: Ceftriaxone; Drug: Ceftaroline fosamil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01530763

P903-31

Details and patient eligibility

About

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia 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 Community Acquired Bacterial Pneumonia (CABP)

Enrollment: 161 patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 2 months to < 18 years old.
• Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion criteria

• Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
• Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
• Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
• Non-infectious causes of pulmonary infiltrates.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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161 participants in 2 patient groups

Ceftaroline fosamil

Experimental group

Treatment:

Drug: Ceftaroline fosamil

Drug: amoxicillin clavulanate

Ceftriaxone

Active Comparator group

Treatment:

Drug: Ceftriaxone

Drug: amoxicillin clavulanate