Infections, Pediatrics
Conditions
Keywords
Infections, Pediatrics, Teflaro, cephalosporin
Brief 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).
Interventions
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)
DRUGVancomycin +/- 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
DRUGCephalexin 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.
Sponsors
AstraZeneca
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
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 intervention
Exclusion criteria
* Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial * Uncomplicated skin and soft tissue infections * More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization. * Requirement for any concomitant systemic antimicrobial therapy * History of seizures, excluding well-documented febrile seizure of childhood. * Clinical signs or suspicion of meningitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | Between 26 and 50 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | Between 1 and 5 days | The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinical Evaluable (CE) populations at Day 3, EOIV, EOT and TOC. |
| Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. | Between 1 and 5 days | Analyze concentrations of ceftaroline fosamil, ceftaroline, and M-1 in plasma, and if available, in cerebrospinal fluid (CSF; if collected as part of routine medical care) |
Countries
Argentina, Chile, Georgia, Latvia, Lithuania, Poland, Romania, South Africa, Spain, United States
Outcome results
None listed