Clinical Trial: Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pne

Brief Summary: The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Detailed Summary: Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
Sponsor: Forest Laboratories

Current Primary Outcome:

  • Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population [ Time Frame: 8-15 days after last dose of study drug ]

    Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

    Failure: Any of the following:

    • Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
    • Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
    • Death wherein pneumonia (ie,CABP) was considered causative

    Indeterminate: Inability to determine an outcome

  • Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population [ Time Frame: 8-15 days after last dose of study drug ]


Original Primary Outcome:

Current Secondary Outcome:

  • Clinical Response at End of Therapy (EOT) [ Time Frame: Last day of study drug administration ]
  • Microbiological Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  • Overall Clinical and Radiographic Success Rate at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  • Clinical and Microbiological Response by Pathogen at TOC [ Time Frame: 8-15 days after last dose of study drug ]
  • Clinical Relapse at Late Follow Up (LFU) Visit [ Time Frame: 21-35 days after last dose of study drug ]
  • Microbiological Reinfection/Recurrence at LFU [ Time Frame: 21 to 35 days after last dose of study drug ]
  • Evaluate Safety [ Time Frame: first dose, throughout the treatment period, and up to the TOC visit ]


Original Secondary Outcome:

Information By: Forest Laboratories

Dates:
Date Received: July 27, 2007
Date Started: July 2007
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017