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.
Brief Title
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
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).
Completion Date
Completion Date Type
Actual
Conditions
Infections, Pediatrics
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Infections
Pediatrics
Teflaro
cephalosporin
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
2 Months
NCT Id
NCT01400867
Org Class
Industry
Org Full Name
Forest Laboratories
Org Study Id
P903-23
Overall Status
Completed
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Outcome Time Frame
Between 26 and 50 days.
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Between 1 and 5 days
Outcome Measure
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Outcome Description
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)
Outcome Time Frame
Between 1 and 5 days
Outcome Measure
Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tsoline kojaoghlanian
Investigator Email
Investigator Phone