Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

Study Overview
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Brief Summary
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Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics together. These antibiotics usually include a cephalosporin and a macrolide. The most commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline. This research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in hospitalized patients based on two research studies. In one study, ceftaroline was better than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone. Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.

Official Title
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Ceftaroline Fosamil Versus Standard of Care for Community Acquired Bacterial Pneumonia (CABP): Clinical Outcomes Among Hospitalized Adults at a Single United States Hospital

Conditions
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Community Acquired Bacterial Pneumonia

Intervention / Treatment
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* Drug: Efficacy of ceftaroline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older met ATS/ISDA criteria rule of CABP CABP requiring hospitalization and treatment with a IV antimicrobial anticipated hospitalization for > 48 hours received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for > 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV Exclusion Criteria: CABP PORT Risk class I, II, III CABP requiring admission to an ICU CABP suitable for outpatient therapy with an oral microbial agent confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens noninfectious case of pulmonary infiltrates or pleural empyema infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization receipt of chronic concomitant systemic steroids > 40 mg of prednisone equivalent significant hepatic disease hematologic disease Immunological disease history of a hypersensitivity reaction to beta-lactams pregnant or nursing females

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: Efficacy of ceftaroline|Determining the efficacy of ceftaroline compared to other cephalosporins|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving clinical stability | definition of clinically stable: temperature ≤37.8°C, heart rate ≤100 beats/min, systolic blood pressure ≥90 mm Hg, respiratory rate ≤24 breaths/min, oxygen saturation ≥90% or pO2 ≥ 60 mm Hg on room air, and normal mental status; none of the following symptoms worsening: cough, dyspnea, chest pain, sputum production; and ≥ 1 of the aforementioned symptoms improving. | day 2 | 
| Achieving clinical stability | definition of clinically stable: temperature ≤37.8°C, heart rate ≤100 beats/min, systolic blood pressure ≥90 mm Hg, respiratory rate ≤24 breaths/min, oxygen saturation ≥90% or pO2 ≥ 60 mm Hg on room air, and normal mental status; none of the following symptoms worsening: cough, dyspnea, chest pain, sputum production; and ≥ 1 of the aforementioned symptoms improving. | day 3 | 
| Achieving clinical stability | definition of clinically stable: temperature ≤37.8°C, heart rate ≤100 beats/min, systolic blood pressure ≥90 mm Hg, respiratory rate ≤24 breaths/min, oxygen saturation ≥90% or pO2 ≥ 60 mm Hg on room air, and normal mental status; none of the following symptoms worsening: cough, dyspnea, chest pain, sputum production; and ≥ 1 of the aforementioned symptoms improving. | day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving clinical stability | definition of clinically stable: temperature ≤37.8°C, heart rate ≤100 beats/min, systolic blood pressure ≥90 mm Hg, respiratory rate ≤24 breaths/min, oxygen saturation ≥90% or pO2 ≥ 60 mm Hg on room air, and normal mental status; none of the following symptoms worsening: cough, dyspnea, chest pain, sputum production; and ≥ 1 of the aforementioned symptoms improving. | day 5 | 
| Hospital Readmission | medical record review to note if subject re-admitted within past 30 days | day 30 | 
| All-cause mortality | medical record review to identify if subject mortality occured within past 30 days | day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, community acquired bacterial pneumonia, CAP, CABP, bacterial pneumonia