Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

August 31, 2014

Conditions
InfectionsPneumonia
Interventions
DRUG

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"

DRUG

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"

Trial Locations (21)

Unknown

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

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY