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Study Status: Withdrawn
Recruit Status: Withdrawn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