Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections

Completed · Phase 2/Phase 3

Conditions studied: Infections, Pediatrics

In brief

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.

Key facts

Study ID

NCT01400867

Run by

Forest Laboratories

People needed

163

Starts

2011-12-01

Expected to finish

2014-07-01

Last updated by the study team

2015-01-13

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Investigational Site - Detroit — Detroit, Michigan, United States
• Investigational Site - Brooklyn — Brooklyn, New York, United States
• Investigational Site - New Hyde Park — New Hyde Park, New York, United States
• Investigational Site - Rochester — Rochester, New York, United States
• Investigational Site - Bronx — The Bronx, New York, United States
• Investigational Site - Akron — Akron, Ohio, United States
• Investigational Site - Cleveland 1 — Cleveland, Ohio, United States
• Investigational Site - Cleveland 2 — Cleveland, Ohio, United States
• Investigational Site - Toledo — Toledo, Ohio, United States
• Investigational Site - Pittsburgh — Pittsburgh, Pennsylvania, United States
• Investigational Site - Charleston — Charleston, South Carolina, United States
• Investigational Site - Memphis — Memphis, Tennessee, United States
• Investigational Site - Austin 1 — Austin, Texas, United States
• Investigational Site - Fort Worth — Fort Worth, Texas, United States
• Investigational Site - Norfolk — Norfolk, Virginia, United States
• Investigational Site - Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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