NCT01669980

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

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Infections
• Pneumonia

Interventions

Type	Name	Description
DRUG	Ceftaroline fosamil	* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) * Subjects \< 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour) Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
DRUG	IV Ceftriaxone and Vancomycin	* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND * IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2012-08-21
• Last updated: 2015-11-02

Locations

21 sites across 4 countries: United States, Argentina, Georgia, Ukraine