NCT01400867

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

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Infections, Pediatrics

Interventions

Type	Name	Description
DRUG	Ceftaroline fosamil	Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing \> 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Subjects \< 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
DRUG	Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam	Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed) Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed
DRUG	Cephalexin or Clindamycin or Linezolid	Possible oral switch on or after study day 4. Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2011-07-22
• Last updated: 2015-01-13

Locations

71 sites across 10 countries: United States, Argentina, Chile, Georgia, Latvia, Lithuania, Poland, Romania, South Africa, Spain