Clinical Trial: Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects 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, With Adjunctive Clarithromycin, in the Treatment of Adult Sub

Brief Summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Detailed Summary: The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries
Sponsor: Forest Laboratories

Current Primary Outcome:

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


Original Primary Outcome: Determine the non-inferiority of ceftaroline compared to that for ceftriaxone in adult subjects with community-acquired pneumonia (CAP) [ Time Frame: Test-of-Cure (TOC) ]

Current Secondary Outcome:

  • Clinical Response at End of Therapy (EOT) [ Time Frame: Last day of study drug administration ]
  • Microbiological Success Rate at Test of Cure (TOC) [ Time Frame: 8-15 days after last dose of study drug ]
  • Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) [ Time Frame: 8-15 days after last day 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) [ Time Frame: 21-35 days after last dose of study drug ]
  • Microbiological Re-infection/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: February 11, 2008
Date Started: January 2008
Date Completion:
Last Updated: February 2, 2017
Last Verified: February 2017