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Change in strategy.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftaroline fosamil | Experimental | IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) |
|
| 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:
| Between 3 and 33-37 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) | Efficacy outcome measures:
| 30 days following discharge from the hospital, anticipated between 33 to 37 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D007239 | Infections |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |