Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
NCT ID: NCT01400867
Last Updated: 2015-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
163 participants
INTERVENTIONAL
2011-12-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ceftaroline fosamil
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)
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.
Comparators
Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam
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
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.
Interventions
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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)
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Months
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Locations
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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 - 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 - Bronx
The Bronx, 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 - 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
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 - Puente Alto
Puente Alto, Santiago Metropolitan, Chile
Investigational Site - San Ramon
San Ramón, Santiago Metropolitan, Chile
Investigational Site - Vitacura
Vitacura, Santiago Metropolitan, Chile
Investigational Site - Vina Del Mar
Viña del Mar, , Chile
Investigational Site - Tbilisi 1
Tbilisi, , Georgia
Investigational Site - Tbilisi 2
Tbilisi, , Georgia
Investigational Site - Daugavpils
Daugavpils, , Latvia
Investigational Site - Liepaja
Liepāja, , Latvia
Investigational Site - Rezekne
Rēzekne, , 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
Rzeszów, , Poland
Investigational Site - Warszawa
Warsaw, , Poland
Investigational Site - Bucharest 1
Bucharest, , Romania
Investigational Site - Bucharest 2
Bucharest, , Romania
Investigational Site - Constanta
Constanța, , Romania
Investigational Site - Tirgu Mures
Târgu Mureş, , Romania
Investigational Site - Timisoara
Timișoara, , 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
Countries
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Related Links
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Related Info
Other Identifiers
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P903-23
Identifier Type: -
Identifier Source: org_study_id
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