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

This study has been completed.
Sponsor:
Collaborators:
Albany College of Pharmacy and Health Sciences
Forest Laboratories
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01605864
First received: May 16, 2012
Last updated: March 20, 2014
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Community Acquired Bacterial Pneumonia
Drug: Efficacy of ceftaroline
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Albany Medical College:

Primary Outcome Measures:
  • Achieving clinical stability [ Time Frame: day 2 ] [ Designated as safety issue: No ]
    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.

  • Achieving clinical stability [ Time Frame: day 3 ] [ Designated as safety issue: No ]
    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.

  • Achieving clinical stability [ Time Frame: day 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Achieving clinical stability [ Time Frame: day 5 ] [ Designated as safety issue: No ]
    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.

  • Hospital Readmission [ Time Frame: day 30 ] [ Designated as safety issue: No ]
    medical record review to note if subject re-admitted within past 30 days

  • All-cause mortality [ Time Frame: day 30 ] [ Designated as safety issue: No ]
    medical record review to identify if subject mortality occured within past 30 days


Enrollment: 12
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Efficacy of ceftaroline
    Determining the efficacy of ceftaroline compared to other cephalosporins
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605864

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12204
Sponsors and Collaborators
Albany Medical College
Albany College of Pharmacy and Health Sciences
Forest Laboratories
Investigators
Principal Investigator: Wayne Triner, DO, MPH Albany Medical College
Principal Investigator: Tom Lodise, PharmD Albany College of Pharmacy and Health Sciences
  More Information

No publications provided

Responsible Party: Wayne Triner, Professor and Research Director Dept.of Emergency Medicine, Albany Medical College
ClinicalTrials.gov Identifier: NCT01605864     History of Changes
Other Study ID Numbers: 3216
Study First Received: May 16, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Albany Medical College:
pneumonia
community acquired bacterial pneumonia
CAP
CABP
bacterial pneumonia

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 23, 2014