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

Completed · Phase 2/Phase 3

Conditions studied: Infections, Community Acquired Pneumonia

In brief

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

Key facts

Study ID

NCT01530763

Run by

Forest Laboratories

People needed

161

Starts

2012-09-01

Expected to finish

2014-07-01

Last updated by the study team

2015-01-13

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 2 months to < 18 years old.
• Presence of CABP requiring hospitalization and IV antibacterial therapy

You may not qualify if…

• Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
• Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
• Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
• Non-infectious causes of pulmonary infiltrates.

Where it is running

• Investigational Site — Long Beach, California, United States
• Investigational Site — Oakland, California, United States
• Investigational Site — Orange, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — Boston, Massachusetts, United States
• Investigational Site — Syracuse, New York, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational Site — Toledo, Ohio, United States
• Investigational Site — Pittsuburg, Pennsylvania, United States
• Investigational Site — Memphis, Tennessee, United States
• Investigational Site — Houston, Texas, United States
• Investigational Site — Salt Lake City, Utah, United States
• Investigational Site — Morgantown, West Virginia, United States
• Investigational Site — Capital Federal, Buenos Aires, Argentina
• Investigational Site — Córdoba, Córdoba Province, Argentina
• Investigational Site — Plovdiv, Bulgaria
• Investigational Site — Rousse, Bulgaria
• Investigational Site2 — Sofia, Bulgaria
• Investigational Site — Sofia, Bulgaria
• Investigational Site2 — Tbilisi, Georgia
• Investigational Site3 — Tbilisi, Georgia
• Investigational Site — Tbilisi, Georgia
• Investigational Site — Athens, Attica, Greece
• Investigational Site — Heraklion, Crete, Greece
• Investigational Site — Thessaloniki, Macedonia, Greece

Full record on ClinicalTrials.gov

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