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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections, Pediatrics

Intervention: Ceftaroline fosamil (Drug); Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam (Drug); Cephalexin or Clindamycin or Linezolid (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Forest Laboratories

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.

Secondary outcome:

Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.

Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.

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

Minimum age: 2 Months. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Investigational Site - Buenos Aires 1, Buenos Aires, Argentina

Investigational Site - Buenos Aires 2, Buenos Aires, Argentina

Investigational Site - Buenos Aires 3, Buenos Aires, Argentina

Investigational Site - Buenos Aires 4, Buenos Aires, Argentina

Investigational Site - Buenos Aires 5, Buenos Aires, Argentina

Investigational Site - Buenos Aires 6, Buenos Aires, Argentina

Investigational Site - Santa Fe 1, Santa Fe, Argentina

Investigational Site - Santa Fe 2, Santa Fe, Argentina

Investigational Site - Vina Del Mar, Vina del Mar, Chile

Investigational Site - Tbilisi 1, Tbilisi, Georgia

Investigational Site - Tbilisi 2, Tbilisi, Georgia

Investigational Site - Daugavpils, Daugavpils, Latvia

Investigational Site - Liepaja, Liepaja, Latvia

Investigational Site - Rezekne, Rezekne, Latvia

Investigational Site - Riga, Riga, Latvia

Investigational Site - Kaunas, Kaunas, Lithuania

Investigational Site - Vilnius, Vilnius, Lithuania

Investigational Site - Bydgoszcz 1, Bydgoszcz, Poland

Investigational Site - Bydgoszcz 2, Bydgoszcz, Poland

Investigational Site - Lodz, Lodz, Poland

Investigational Site - Lublin, Lublin, Poland

Investigational Site - Rzeszow, Rzeszow, Poland

Investigational Site - Warszawa, Warszawa, Poland

Investigational Site - Bucharest 1, Bucharest, Romania

Investigational Site - Bucharest 2, Bucharest, Romania

Investigational Site - Constanta, Constanta, Romania

Investigational Site - Timisoara, Timisoara, Romania

Investigational Site - Tirgu Mures, Tirgu Mures, Romania

Investigational Site - Cape Town 1, Cape Town, South Africa

Investigational Site - Cape Town 2, Cape Town, South Africa

Investigational Site - Cape Town 3, Cape Town, South Africa

Investigational Site - Johannesburg, Johannesburg, South Africa

Investigational Site - Badalona, Badalona, Spain

Investigational Site - Esplugues de Llobregat, Esplugues de Llobregat, Spain

Investigational Site - Getafe, Getafe, Spain

Investigational Site - Madrid 1, Madrid, Spain

Investigational Site - Madrid 2, Madrid, Spain

Investigational Site - Madrid 3, Madrid, Spain

Investigational Site - Santiago de Compostela, Santiago de Compostela, Spain

Investigational Site - Valencia, Valencia, Spain

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, 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 - Bronx, Bronx, New York, 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 - 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 - Puente Alto, Puente Alto, Santiago, Chile

Investigational Site - San Ramon, San Ramon, Santiago, Chile

Investigational Site - Vitacura, Vitacura, Santiago, Chile

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 - Richmond, Richmond, Virginia, United States

Investigational Site - Seattle, Seattle, Washington, United States

Investigational Site - Morgantown, Morgantown, West Virginia, United States

Additional Information

Starting date: December 2011
Last updated: January 12, 2015

Page last updated: August 23, 2015

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