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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

May 16, 2012
March 20, 2014
May 2012
March 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01605864 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Community Acquired Bacterial Pneumonia
Drug: Efficacy of ceftaroline
Determining the efficacy of ceftaroline compared to other cephalosporins
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605864
3216
No
Wayne Triner, Albany Medical College
Albany Medical College
  • Albany College of Pharmacy and Health Sciences
  • Forest Laboratories
Principal Investigator: Wayne Triner, DO, MPH Albany Medical College
Principal Investigator: Tom Lodise, PharmD Albany College of Pharmacy and Health Sciences
Albany Medical College
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP