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