NCT01530763 - Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) | Biotech Hunter

Enrollment

161

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

July 31, 2014

Conditions

InfectionsCommunity Acquired Pneumonia

Interventions

DRUG

Ceftaroline fosamil

"Treatment Group 1:~Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing \> 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)~Children \< 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour)"

DRUG

Ceftriaxone

"Treatment group 2:~75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours)"

DRUG

amoxicillin clavulanate

"Oral Switch for Treatment Groups 1 and 2:~PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)"

Trial Locations (44)

Unknown

Investigational Site, Long Beach

Investigational Site, Oakland

Investigational Site, Orange

Investigational Site, San Diego

Investigational Site, Boston

Investigational Site, Syracuse

Investigational Site, Cleveland

Investigational Site, Toledo

Investigational Site, Pittsuburg

Investigational Site, Memphis

Investigational Site, Houston

Investigational Site, Salt Lake City

Investigational Site, Morgantown

Investigational Site, Capital Federal

Investigational Site, Córdoba

Investigational Site, Plovdiv

Investigational Site, Rousse

Investigational Site2, Sofia

Investigational Site, Sofia

Investigational Site2, Tbilisi

Investigational Site3, Tbilisi

Investigational Site, Tbilisi

Investigational Site, Athens

Investigational Site, Heraklion

Investigational Site, Thessaloniki

Investigational Site, Larissa

Investigational Site, Gyula

Investigational Site, Ajka

Investigational Site, Budapest

Investigational Site, Nagykanisza

Investigational Site, Nyíregyháza

Investigational Site, Szeged

Investigational Site, Veszprém

Investigational Site, Zalaegerszeg

Investigational Site, Lublin

Investigational Site, Rzeszów

Investigational Site, Warsaw

Investigational Site, Madrid

Investigational Site, Córdoba

Investigational Site, Donetsk

Investigational Site, Ivano-Frankivsk

Investigational Site, Kryvyi Rih

Investigational Site, Kyiv

Investigational Site, Zaporizhia