Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftaroline fosamil · 1 trial · 1 indication
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.
| Arm | Type | Description |
|---|---|---|
| Ceftaroline fosamil | EXPERIMENTAL | - |
| Comparators | ACTIVE_COMPARATOR | Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam |
| Name | Type | Description |
|---|---|---|
| Ceftaroline fosamil | DRUG | 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) |
| Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam | DRUG | 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 |
| Cephalexin or Clindamycin or Linezolid | DRUG | 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. |
Inclusion Criteria: * Male or female, 2 months to \< 18 years old. * Presence of ABSSSI warranting initial hospitalization. * Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervent...
Ceftaroline fosamil is an investigational small molecule being studied for the treatment of infections in pediatric patients. It is being evaluated specifically for complicated skin infections in children aged 2 months and older. The drug is currently in Phase 2 clinical development.
Ceftaroline fosamil is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric patients with complicated skin infections.
Ceftaroline fosamil is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its safety and efficacy in pediatric subjects with complicated skin infections.
Ceftaroline fosamil has one completed Phase 2 clinical trial registered as NCT01400867. This study evaluated the safety and efficacy of ceftaroline versus a comparator in pediatric subjects with complicated skin infections. The trial enrolled 163 participants across multiple countries including the United States, Argentina, Chile, and Spain.
Ceftaroline fosamil is a small molecule antibiotic. It works by interfering with bacterial cell wall synthesis, which is essential for bacterial growth and survival. This mechanism makes it effective against certain bacterial infections, particularly complicated skin infections in pediatric patients.