Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia (CAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Community Acquired Bacterial Pneumonia
• Intervention / Treatment: Drug: Efficacy of ceftaroline

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12204
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Collaborators: Forest Laboratories; Albany College of Pharmacy and Health Sciences
• Investigators: Principal Investigator: Wayne Triner, DO, MPH, Albany Medical College; Principal Investigator: Tom Lodise, PharmD, Albany College of Pharmacy and Health Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: pneumonia; CAP; CABP; bacterial pneumonia; community acquired bacterial pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Ceftaroline fosamil
• Other Study ID Numbers: 3216