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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01400867
First received: July 19, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Infections, Pediatrics
Drug: Ceftaroline fosamil
Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam
Drug: Cephalexin or Clindamycin or Linezolid
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Between 1 and 5 days ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 270
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

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.


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

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400867

  Hide Study Locations
Locations
United States, Arizona
Investigational Site - Phoenix
Phoenix, Arizona, United States
United States, California
Investigational Site - Orange
Orange, California, United States
Investigational Site - San Diego
San Diego, California, United States
United States, Florida
Investigational Site - Jacksonville
Jacksonville, Florida, United States
United States, Georgia
Investigational Site - Atlanta
Atlanta, Georgia, United States
United States, Illinois
Investigational Site - Chicago 1
Chicago, Illinois, United States
Investigational Site - Chicago 2
Chicago, Illinois, United States
Investigational Site - Springfield
Springfield, Illinois, United States
United States, Louisiana
Investigational Site - Shreveport
Shreveport, Louisiana, United States
United States, Maryland
Investigational Site - Baltimore
Baltimore, Maryland, United States
United States, Michigan
Investigational Site - Detroit
Detroit, Michigan, United States
United States, New York
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
United States, Ohio
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
United States, Pennsylvania
Investigational Site - Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Investigational Site - Charleston
Charleston, South Carolina, United States
United States, Tennessee
Investigational Site - Memphis
Memphis, Tennessee, United States
United States, Texas
Investigational Site - Austin 1
Austin, Texas, United States
Investigational Site - Fort Worth
Fort Worth, Texas, United States
United States, Virginia
Investigational Site - Norfolk
Norfolk, Virginia, United States
Investigational Site - Richmond
Richmond, Virginia, United States
United States, Washington
Investigational Site - Seattle
Seattle, Washington, United States
United States, West Virginia
Investigational Site - Morgantown
Morgantown, West Virginia, United States
Argentina
Investigational Site - Buenos Aires 1
Buenos Aires, Argentina
Investigational Site - Buenos Aires 5
Buenos Aires, Argentina
Investigational Site - Buenos Aires 3
Buenos Aires, Argentina
Investigational Site - Buenos Aires 4
Buenos Aires, Argentina
Investigational Site - Buenos Aires 2
Buenos Aires, Argentina
Investigational Site - Buenos Aires 6
Buenos Aires, Argentina
Investigational Site - Santa Fe 2
Santa Fe, Argentina
Investigational Site - Santa Fe 1
Santa Fe, Argentina
Chile
Investigational Site - Puente Alto
Puente Alto, Santiago, Chile
Investigational Site - San Ramon
San Ramon, Santiago, Chile
Investigational Site - Vitacura
Vitacura, Santiago, Chile
Investigational Site - Vina Del Mar
Vina del Mar, Chile
Georgia
Investigational Site - Tbilisi 1
Tbilisi, Georgia
Investigational Site - Tbilisi 2
Tbilisi, Georgia
Latvia
Investigational Site - Daugavpils
Daugavpils, Latvia
Investigational Site - Liepaja
Liepaja, Latvia
Investigational Site - Rezekne
Rezekne, Latvia
Investigational Site - Riga
Riga, Latvia
Lithuania
Investigational Site - Kaunas
Kaunas, Lithuania
Investigational Site - Vilnius
Vilnius, Lithuania
Poland
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
Romania
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
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
Cape Town, South Africa
Investigational Site - Johannesburg
Johannesburg, South Africa
Spain
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
Sponsors and Collaborators
Cerexa, Inc.
AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01400867     History of Changes
Other Study ID Numbers: P903-23
Study First Received: July 19, 2011
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerexa, Inc.:
Infections
Pediatrics
Teflaro
cephalosporin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vancomycin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cefazolin
Cephalexin
Aztreonam
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014