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

January 12, 2015 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 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
      • Santa Fe, Argentina
        • Investigational Site - Santa Fe 1
      • Santa Fe, Argentina
        • Investigational Site - Santa Fe 2
  • Chile
      • Vina del Mar, Chile
        • Investigational Site - Vina Del Mar
    • Santiago
      • Puente Alto, Santiago, Chile
        • Investigational Site - Puente Alto
      • San Ramon, Santiago, Chile
        • Investigational Site - San Ramon
      • Vitacura, Santiago, Chile
        • Investigational Site - Vitacura
  • Georgia
      • Tbilisi, Georgia
        • Investigational Site - Tbilisi 1
      • Tbilisi, Georgia
        • Investigational Site - Tbilisi 2
  • Latvia
      • Daugavpils, Latvia
        • Investigational Site - Daugavpils
      • Liepaja, Latvia
        • Investigational Site - Liepaja
      • Rezekne, Latvia
        • Investigational Site - Rezekne
      • Riga, Latvia
        • Investigational Site - Riga
  • Lithuania
      • Kaunas, Lithuania
        • Investigational Site - Kaunas
      • Vilnius, Lithuania
        • Investigational Site - Vilnius
  • Poland
      • Bydgoszcz, Poland
        • Investigational Site - Bydgoszcz 1
      • Bydgoszcz, Poland
        • Investigational Site - Bydgoszcz 2
      • Lodz, Poland
        • Investigational Site - Lodz
      • Lublin, Poland
        • Investigational Site - Lublin
      • Rzeszow, Poland
        • Investigational Site - Rzeszow
      • Warszawa, Poland
        • Investigational Site - Warszawa
  • Romania
      • Bucharest, Romania
        • Investigational Site - Bucharest 1
      • Bucharest, Romania
        • Investigational Site - Bucharest 2
      • Constanta, Romania
        • Investigational Site - Constanta
      • Timisoara, Romania
        • Investigational Site - Timisoara
      • Tirgu Mures, Romania
        • Investigational Site - Tirgu Mures
  • South Africa
      • Cape Town, South Africa
        • Investigational Site - Cape Town 1
      • Cape Town, South Africa
        • Investigational Site - Cape Town 2
      • Cape Town, South Africa
        • Investigational Site - Cape Town 3
      • Johannesburg, South Africa
        • Investigational Site - Johannesburg
  • Spain
      • Badalona, Spain
        • Investigational Site - Badalona
      • Esplugues de Llobregat, Spain
        • Investigational Site - Esplugues de Llobregat
      • Getafe, Spain
        • Investigational Site - Getafe
      • Madrid, Spain
        • Investigational Site - Madrid 1
      • Madrid, Spain
        • Investigational Site - Madrid 2
      • Madrid, Spain
        • Investigational Site - Madrid 3
      • Santiago de Compostela, Spain
        • Investigational Site - Santiago de Compostela
      • Valencia, Spain
        • Investigational Site - Valencia
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Investigational Site - Phoenix
    • California
      • Orange, California, United States
        • Investigational Site - Orange
      • San Diego, California, United States
        • Investigational Site - San Diego
    • Florida
      • Jacksonville, Florida, United States
        • Investigational Site - Jacksonville
    • Georgia
      • Atlanta, Georgia, United States
        • Investigational Site - Atlanta
    • Illinois
      • Chicago, Illinois, United States
        • Investigational Site - Chicago 1
      • Chicago, Illinois, United States
        • Investigational Site - Chicago 2
      • Springfield, Illinois, United States
        • Investigational Site - Springfield
    • Louisiana
      • Shreveport, Louisiana, United States
        • Investigational Site - Shreveport
    • Maryland
      • Baltimore, Maryland, United States
        • Investigational Site - Baltimore
    • Michigan
      • Detroit, Michigan, United States
        • Investigational Site - Detroit
    • New York
      • Bronx, New York, United States
        • Investigational Site - Bronx
      • Brooklyn, New York, United States
        • Investigational Site - Brooklyn
      • New Hyde Park, New York, United States
        • Investigational Site - New Hyde Park
      • Rochester, New York, United States
        • Investigational Site - Rochester
    • Ohio
      • Akron, Ohio, United States
        • Investigational Site - Akron
      • Cleveland, Ohio, United States
        • Investigational Site - Cleveland 1
      • Cleveland, Ohio, United States
        • Investigational Site - Cleveland 2
      • Toledo, Ohio, United States
        • Investigational Site - Toledo
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Investigational Site - Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States
        • Investigational Site - Charleston
    • Tennessee
      • Memphis, Tennessee, United States
        • Investigational Site - Memphis
    • Texas
      • Austin, Texas, United States
        • Investigational Site - Austin 1
      • Fort Worth, Texas, United States
        • Investigational Site - Fort Worth
    • Virginia
      • Norfolk, Virginia, United States
        • Investigational Site - Norfolk
      • Richmond, Virginia, United States
        • Investigational Site - Richmond
    • Washington
      • Seattle, Washington, United States
        • Investigational Site - Seattle
    • West Virginia
      • Morgantown, West Virginia, United States
        • Investigational Site - Morgantown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ceftaroline fosamil
Drug: Ceftaroline fosamil

Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)

Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)

Other Names:
  • Teflaro
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
Drug: Cephalexin or Clindamycin or Linezolid

Possible oral switch on or after study day 4.

Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.
Active Comparator: Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
Drug: Cephalexin or Clindamycin or Linezolid

Possible oral switch on or after study day 4.

Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.

Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam

Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)

Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time Frame: 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.
Between 26 and 50 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time Frame: 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.
Between 1 and 5 days
Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time Frame: 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)
Between 1 and 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P903-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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