Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia
Status: | Completed |
---|---|
Conditions: | Pneumonia |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | November 2012 |
End Date: | March 2014 |
Contact: | Cerexa Trial Coordinator |
Email: | clinicaltrials@cerexa.com |
Phone: | 510-285-9200 |
A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
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.
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.
Inclusion Criteria:
1. Male or female ≥ 65 years of age.
2. Presence of CABP warranting hospitalization.
3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract
infection.
4. Radiographically confirmed pneumonia.
Exclusion Criteria:
1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide
antibacterial agent.
2. Confirmed or suspected respiratory tract infection due solely to an atypical
bacterial, mycobacterial, viral, or fungal pathogen.
3. More than 24 hours of potentially effective antibacterial therapy within 96 hours
prior to enrollment.
4. Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR).
5. Evidence of significant hematologic, hepatic, or immunologic impairment.
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