Clinical trial NCT01400867: Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infections, Pediatrics
Keywords: Infections
Pediatrics
Teflaro
cephalosporin
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2011-07-22
Enrollment: 163
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
timeFrame: Between 26 and 50 days.
Secondary outcomes:
measure: Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
timeFrame: Between 1 and 5 days
measure: Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
timeFrame: Between 1 and 5 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site - Phoenix
state: Arizona
city: Orange
country: United States
facility: Investigational Site - Orange
state: California
city: San Diego
country: United States
facility: Investigational Site - San Diego
state: California
city: Jacksonville
country: United States
facility: Investigational Site - Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Investigational Site - Atlanta
state: Georgia
city: Chicago
country: United States
facility: Investigational Site - Chicago 1
state: Illinois
city: Chicago
country: United States
facility: Investigational Site - Chicago 2
state: Illinois
city: Springfield
country: United States
facility: Investigational Site - Springfield
state: Illinois
city: Shreveport
country: United States
facility: Investigational Site - Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site - Baltimore
state: Maryland
city: Detroit
country: United States
facility: Investigational Site - Detroit
state: Michigan
city: Bronx
country: United States
facility: Investigational Site - Bronx
state: New York
city: Brooklyn
country: United States
facility: Investigational Site - Brooklyn
state: New York
city: New Hyde Park
country: United States
facility: Investigational Site - New Hyde Park
state: New York
city: Rochester
country: United States
facility: Investigational Site - Rochester
state: New York
city: Akron
country: United States
facility: Investigational Site - Akron
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site - Cleveland 1
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site - Cleveland 2
state: Ohio
city: Toledo
country: United States
facility: Investigational Site - Toledo
state: Ohio
city: Pittsburgh
country: United States
facility: Investigational Site - Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site - Charleston
state: South Carolina
city: Memphis
country: United States
facility: Investigational Site - Memphis
state: Tennessee
city: Austin
country: United States
facility: Investigational Site - Austin 1
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site - Fort Worth
state: Texas
city: Norfolk
country: United States
facility: Investigational Site - Norfolk
state: Virginia
city: Richmond
country: United States
facility: Investigational Site - Richmond
state: Virginia
city: Seattle
country: United States
facility: Investigational Site - Seattle
state: Washington
city: Morgantown
country: United States
facility: Investigational Site - Morgantown
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 1
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 2
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 3
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 4
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 5
city: Buenos Aires
country: Argentina
facility: Investigational Site - Buenos Aires 6
city: Santa Fe
country: Argentina
facility: Investigational Site - Santa Fe 1
city: Santa Fe
country: Argentina
facility: Investigational Site - Santa Fe 2
city: Puente Alto
country: Chile
facility: Investigational Site - Puente Alto
state: Santiago
city: San Ramon
country: Chile
facility: Investigational Site - San Ramon
state: Santiago
city: Vitacura
country: Chile
facility: Investigational Site - Vitacura
state: Santiago
city: Vina del Mar
country: Chile
facility: Investigational Site - Vina Del Mar
city: Tbilisi
country: Georgia
facility: Investigational Site - Tbilisi 1
city: Tbilisi
country: Georgia
facility: Investigational Site - Tbilisi 2
city: Daugavpils
country: Latvia
facility: Investigational Site - Daugavpils
city: Liepaja
country: Latvia
facility: Investigational Site - Liepaja
city: Rezekne
country: Latvia
facility: Investigational Site - Rezekne
city: Riga
country: Latvia
facility: Investigational Site - Riga
city: Kaunas
country: Lithuania
facility: Investigational Site - Kaunas
city: Vilnius
country: Lithuania
facility: Investigational Site - Vilnius
city: Bydgoszcz
country: Poland
facility: Investigational Site - Bydgoszcz 1
city: Bydgoszcz
country: Poland
facility: Investigational Site - Bydgoszcz 2
city: Lodz
country: Poland
facility: Investigational Site - Lodz
city: Lublin
country: Poland
facility: Investigational Site - Lublin
city: Rzeszow
country: Poland
facility: Investigational Site - Rzeszow
city: Warszawa
country: Poland
facility: Investigational Site - Warszawa
city: Bucharest
country: Romania
facility: Investigational Site - Bucharest 1
city: Bucharest
country: Romania
facility: Investigational Site - Bucharest 2
city: Constanta
country: Romania
facility: Investigational Site - Constanta
city: Timisoara
country: Romania
facility: Investigational Site - Timisoara
city: Tirgu Mures
country: Romania
facility: Investigational Site - Tirgu Mures
city: Cape Town
country: South Africa
facility: Investigational Site - Cape Town 1
city: Cape Town
country: South Africa
facility: Investigational Site - Cape Town 2
city: Cape Town
country: South Africa
facility: Investigational Site - Cape Town 3
city: Johannesburg
country: South Africa
facility: Investigational Site - Johannesburg
city: Badalona
country: Spain
facility: Investigational Site - Badalona
city: Esplugues de Llobregat
country: Spain
facility: Investigational Site - Esplugues de Llobregat
city: Getafe
country: Spain
facility: Investigational Site - Getafe
city: Madrid
country: Spain
facility: Investigational Site - Madrid 1
city: Madrid
country: Spain
facility: Investigational Site - Madrid 2
city: Madrid
country: Spain
facility: Investigational Site - Madrid 3
city: Santiago de Compostela
country: Spain
facility: Investigational Site - Santiago de Compostela
city: Valencia
country: Spain
facility: Investigational Site - Valencia
Study officials:
References: