Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
- Conditions
- Infections, Pediatrics
- Interventions
- Registration Number
- NCT01400867
- Lead Sponsor
- Forest Laboratories
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftaroline fosamil Cephalexin or Clindamycin or Linezolid - Comparators Cephalexin or Clindamycin or Linezolid Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam Comparators Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam Ceftaroline fosamil Ceftaroline fosamil -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (71)
Investigational Site - Phoenix
🇺🇸Phoenix, Arizona, United States
Investigational Site - Orange
🇺🇸Orange, California, United States
Investigational Site - San Diego
🇺🇸San Diego, California, United States
Investigational Site - Jacksonville
🇺🇸Jacksonville, Florida, United States
Investigational Site - Atlanta
🇺🇸Atlanta, Georgia, United States
Investigational Site - Chicago 1
🇺🇸Chicago, Illinois, United States
Investigational Site - Chicago 2
🇺🇸Chicago, Illinois, United States
Investigational Site - Springfield
🇺🇸Springfield, Illinois, United States
Investigational Site - Shreveport
🇺🇸Shreveport, Louisiana, United States
Investigational Site - Baltimore
🇺🇸Baltimore, Maryland, United States
Scroll for more (61 remaining)Investigational Site - Phoenix🇺🇸Phoenix, Arizona, United States