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

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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ceftaroline fosamilCephalexin or Clindamycin or Linezolid-
ComparatorsCephalexin or Clindamycin or LinezolidVancomycin +/- Aztreonam Cefazolin +/- Aztreonam
ComparatorsVancomycin +/- Aztreonam or Cefazolin +/- AztreonamVancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Ceftaroline fosamilCeftaroline fosamil-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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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

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Baltimore, Maryland, United States

Scroll for more (61 remaining)
Investigational Site - Phoenix
🇺🇸Phoenix, Arizona, United States

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