Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
Information source: Cerexa, Inc.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Pediatrics
Intervention: Ceftaroline fosamil (Drug); Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam (Drug); Cephalexin or Clindamycin or Linezolid (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Cerexa, Inc. Overall contact:
Cerexa Trial Coordinator, Phone: 510-285-9200, Email: clinicaltrials@cerexa.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Secondary outcome: Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
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).
Eligibility
Minimum age: 2 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cerexa Trial Coordinator, Phone: 510-285-9200, Email: clinicaltrials@cerexa.com
Investigational Site, Santa Fe, Argentina; Recruiting
Investigational Site, Tbilisi, Georgia; Recruiting
Investigational Site, Daugavpils, Latvia; Recruiting
Investigational Site, Liepaja, Latvia; Recruiting
Investigational Site, Rezekne, Latvia; Recruiting
Investigational Site, Riga, Latvia; Recruiting
Investigational Site, Cape Town, South Africa; Recruiting
Investigational Site, Johannesburg, South Africa; Recruiting
Investigational Site, Phoenix, Arizona, United States; Recruiting
Investigational Site, Orange, California, United States; Recruiting
Investigational Site, San Diego, California, United States; Recruiting
Investigational Site, Jacksonville, Florida, United States; Recruiting
Investigational Site, Chicago, Illinois, United States; Recruiting
Investigational Site, Shreveport, Louisiana, United States; Recruiting
Investigational Site, New Hyde Park, New York, United States; Recruiting
Investigational site, Akron, Ohio, United States; Recruiting
Investigational site, Cleveland, Ohio, United States; Recruiting
Investigational Site, Toledo, Ohio, United States; Recruiting
Investigational Site, Memphis, Tennessee, United States; Recruiting
Investigational Site, Austin, Texas, United States; Recruiting
Investigational Site, Fort Worth, Texas, United States; Recruiting
Investigational Site, Norfolk, Virginia, United States; Recruiting
Investigational Site, Seattle, Washington, United States; Recruiting
Investigational Site, Morgantown, West Virginia, United States; Recruiting
Additional Information
Starting date: December 2011
Last updated: September 27, 2012
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