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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Community-Acquired Bacterial Pneumonia (CABP)

Intervention / Treatment
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* Drug: Ceftaroline fosamil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftaroline fosamil<br>IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) | Drug: Ceftaroline fosamil<br>* IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)<br>* Other names: PPI0903;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-Acquired Pneumonia, Lung, Adult, Infections