Status:
COMPLETED
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
AstraZeneca
Conditions:
Infections, Pediatrics
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
PHASE3
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01400867
Start Date
December 1 2011
End Date
July 1 2014
Last Update
January 13 2015
Active Locations (71)
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1
Investigational Site - Phoenix
Phoenix, Arizona, United States
2
Investigational Site - Orange
Orange, California, United States
3
Investigational Site - San Diego
San Diego, California, United States
4
Investigational Site - Jacksonville
Jacksonville, Florida, United States