Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

Community Acquired Bacterial Pneumonia Clinical Trial

— CAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605864
• Other study ID #: 3216
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2012
• Last updated: March 20, 2014
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Efficacy of ceftaroline
Determining the efficacy of ceftaroline compared to other cephalosporins

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albany Medical College	Albany College of Pharmacy and Health Sciences, Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Hospital Readmission	medical record review to note if subject re-admitted within past 30 days	day 30	No
Secondary	All-cause mortality	medical record review to identify if subject mortality occured within past 30 days	day 30	No