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Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia
A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFebruary 11, 2013
February 1, 2013
10 months
August 14, 2012
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
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.
Between 3 and 33-37 days
Secondary Outcomes (1)
Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
30 days following discharge from the hospital, anticipated between 33 to 37 days.
Study Arms (1)
Ceftaroline fosamil
EXPERIMENTALIV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
Interventions
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
Eligibility Criteria
You may qualify if:
- Male or female ≥ 65 years of age.
- Presence of CABP warranting hospitalization.
- Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
- Radiographically confirmed pneumonia.
You may not qualify if:
- History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
- Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
- More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
- Life expectancy of \< 30 days or presence of an order of Do Not Resuscitate (DNR).
- Evidence of significant hematologic, hepatic, or immunologic impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
March 1, 2014
Last Updated
February 11, 2013
Record last verified: 2013-02