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

Completed · Phase 4

Conditions studied: Infections, Pneumonia

In brief

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

Key facts

Study ID

NCT01669980

Run by

Forest Laboratories

People needed

40

Starts

2012-10-01

Expected to finish

2014-08-01

Last updated by the study team

2015-11-02

Who can join

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

You may qualify if…

• Presence of CABP warranting 3 days of initial hospitalization
• Confirmed presence of indicators of complicated CABP

You may not qualify if…

• Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
• Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
• Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
• Non-infectious causes of pulmonary infiltrates

Where it is running

• Investigational Site — Long Beach, California, United States
• Study site — Oakland, California, United States
• Investigational Site — Orange County, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — Boston, Massachusetts, United States
• Investigational Site — Cleveland, Ohio, United States
• Investigational Site — Toledo, Ohio, United States
• Investigational Site — Pittsburgh, Pennsylvania, United States
• Investigational Site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Investigational Site — Norfolk, Virginia, United States
• Investigational Site — Morgantown, West Virginia, United States
• Investigative Site — Buenos Aires, Argentina
• Investigational Site 1 — Tbilisi, Georgia
• Investigational Site 2 — Tbilisi, Georgia
• Investigational Site 3 — Tbilisi, Georgia
• Investigational Site — Donetsk, Ukraine
• Investigational Site — Ivano-Frankivsk, Ukraine
• Investigational Site — Kryvyi Rih, Ukraine
• Investigational Site — Kyiv, Ukraine

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.