Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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