40
Participants
Start Date
October 31, 2012
Primary Completion Date
May 31, 2014
Study Completion Date
August 31, 2014
Ceftaroline fosamil
"* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)~* Subjects \< 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)~Optional Oral Switch:~* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h~* PO clindamycin 13 mg/kg/dose~* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h"
IV Ceftriaxone and Vancomycin
"* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND~* IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.~Optional Oral Switch:~* PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h~* PO clindamycin 13 mg/kg/dose~* PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h"
Investigational Site, Long Beach
Oakland
Investigational Site, Orange County
Investigational Site, San Diego
Investigational Site, Boston
Investigational Site, Cleveland
Investigational Site, Toledo
Investigational Site, Pittsburgh
Investigational Site, Memphis
Houston
Salt Lake City
Investigational Site, Norfolk
Investigational Site, Morgantown
Investigative Site, Buenos Aires
Investigational Site 1, Tbilisi
Investigational Site 2, Tbilisi
Investigational Site 3, Tbilisi
Investigational Site, Donetsk
Investigational Site, Ivano-Frankivsk
Investigational Site, Kryvyi Rih
Investigational Site, Kyiv
Lead Sponsor
Forest Laboratories
INDUSTRY