Clinical Trial: Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia

Brief Summary: The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.

Detailed Summary: This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.
Sponsor: Forest Laboratories

Current Primary Outcome: Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: Between 3 and 33-37 days ]

Safety evaluations will be conducted and assessments will include:

  • Adverse events including deaths will be evaluated.
  • Laboratory: complete blood count with differential, and chemistry panel.


Original Primary Outcome: Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: Between 3 and 33-37 days ]

Safety evaluations will be conducted and assessments will include:

  • Adverse events including deaths will be evaluated.
  • Clinical: vital signs (pulse, blood pressure, respiratory rate, and temperature) and oxygen saturation.
  • Laboratory: complete blood count with differential, and chemistry panel.


Current Secondary Outcome: Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: 30 days following discharge from the hospital, anticipated between 33 to 37 days. ]

Efficacy outcome measures:

  • Time to clinical stability
  • Length of stay
  • Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure
  • Mortality
  • 30-day readmission


Original Secondary Outcome: Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: Subject participation will require approximately 30 days. ]

Efficacy outcome measures:

  • Time to clinical stability in the modified Intent-to-Treat (MITT) Population
  • Length of stay in the MITT Population
  • Clinical outcome at End-of-Intravenous Study Drug (EOSD), End-of-Therapy (EOT), and Test-of-Cure (TOC) in the MITT Population
  • Mortality (in-hospital and 30-day) in the MITT Population
  • 30-day readmission (for related and unplanned condition and all cause) in the MITT Population


Information By: Forest Laboratories

Dates:
Date Received: August 14, 2012
Date Started: November 2012
Date Completion: March 2014
Last Updated: February 7, 2013
Last Verified: February 2013