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