NCT01400867 - Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections | Biotech Hunter

Enrollment

163

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

May 31, 2014

Study Completion Date

July 31, 2014

Conditions

Infections, Pediatrics

Interventions

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)"

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."

Trial Locations (71)

Unknown

Investigational Site - Phoenix, Phoenix

Investigational Site - Orange, Orange

Investigational Site - San Diego, San Diego

Investigational Site - Jacksonville, Jacksonville

Investigational Site - Atlanta, Atlanta

Investigational Site - Chicago 1, Chicago

Investigational Site - Chicago 2, Chicago

Investigational Site - Springfield, Springfield

Investigational Site - Shreveport, Shreveport

Investigational Site - Baltimore, Baltimore

Investigational Site - Detroit, Detroit

Investigational Site - Brooklyn, Brooklyn

Investigational Site - New Hyde Park, New Hyde Park

Investigational Site - Rochester, Rochester

Investigational Site - Bronx, The Bronx

Investigational Site - Akron, Akron

Investigational Site - Cleveland 1, Cleveland

Investigational Site - Cleveland 2, Cleveland

Investigational Site - Toledo, Toledo

Investigational Site - Pittsburgh, Pittsburgh

Investigational Site - Charleston, Charleston

Investigational Site - Memphis, Memphis

Investigational Site - Austin 1, Austin

Investigational Site - Fort Worth, Fort Worth

Investigational Site - Norfolk, Norfolk

Investigational Site - Richmond, Richmond

Investigational Site - Seattle, Seattle

Investigational Site - Morgantown, Morgantown

Investigational Site - Buenos Aires 1, Buenos Aires

Investigational Site - Buenos Aires 2, Buenos Aires

Investigational Site - Buenos Aires 3, Buenos Aires

Investigational Site - Buenos Aires 4, Buenos Aires

Investigational Site - Buenos Aires 5, Buenos Aires

Investigational Site - Buenos Aires 6, Buenos Aires

Investigational Site - Santa Fe 1, Santa Fe

Investigational Site - Santa Fe 2, Santa Fe

Investigational Site - Puente Alto, Puente Alto

Investigational Site - San Ramon, San Ramón

Investigational Site - Vitacura, Vitacura

Investigational Site - Vina Del Mar, Viña del Mar

Investigational Site - Tbilisi 1, Tbilisi

Investigational Site - Tbilisi 2, Tbilisi

Investigational Site - Daugavpils, Daugavpils

Investigational Site - Liepaja, Liepāja

Investigational Site - Rezekne, Rēzekne

Investigational Site - Riga, Riga

Investigational Site - Kaunas, Kaunas

Investigational Site - Vilnius, Vilnius

Investigational Site - Bydgoszcz 1, Bydgoszcz

Investigational Site - Bydgoszcz 2, Bydgoszcz

Investigational Site - Lodz, Lodz

Investigational Site - Lublin, Lublin

Investigational Site - Rzeszow, Rzeszów

Investigational Site - Warszawa, Warsaw

Investigational Site - Bucharest 1, Bucharest

Investigational Site - Bucharest 2, Bucharest

Investigational Site - Constanta, Constanța

Investigational Site - Tirgu Mures, Târgu Mureş

Investigational Site - Timisoara, Timișoara

Investigational Site - Cape Town 1, Cape Town

Investigational Site - Cape Town 2, Cape Town

Investigational Site - Cape Town 3, Cape Town

Investigational Site - Johannesburg, Johannesburg

Investigational Site - Badalona, Badalona

Investigational Site - Esplugues de Llobregat, Esplugues de Llobregat

Investigational Site - Getafe, Getafe

Investigational Site - Madrid 1, Madrid

Investigational Site - Madrid 2, Madrid

Investigational Site - Madrid 3, Madrid

Investigational Site - Santiago de Compostela, Santiago de Compostela

Investigational Site - Valencia, Valencia