drugset / Trial / NCT01400867
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2014-05
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aztreonam | Small molecule | 30 mg/kg | Intravenous |
| Comparator | Cefazolin | Small molecule | 75 mg/kg | Intravenous |
| Subject | Ceftaroline fosamil | Other / unclassified | 8 mg/kg | Intravenous |
| Subject | Ceftaroline fosamil | Other / unclassified | 12 mg/kg | Intravenous |
| Subject | Ceftaroline fosamil | Other / unclassified | 400 mg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Background | CEPHALEXIN ANHYDROUS | Small molecule | 25 mg/kg | Oral |
| Background | Clindamycin | Unknown | 10 mg/kg | Oral |
| Background | Linezolid | Other / unclassified | 10 mg/kg | Oral |
| Background | Linezolid | Other / unclassified | 600 mg | Oral |