search
Back to results

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

Primary Purpose

Community Acquired Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Efficacy of ceftaroline
Sponsored by
Albany Medical College
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Acquired Bacterial Pneumonia focused on measuring pneumonia, community acquired bacterial pneumonia, CAP, CABP, bacterial pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albany Medical Center

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Hospital Readmission
medical record review to note if subject re-admitted within past 30 days
All-cause mortality
medical record review to identify if subject mortality occured within past 30 days

Full Information

First Posted
May 16, 2012
Last Updated
March 20, 2014
Sponsor
Albany Medical College
Collaborators
Albany College of Pharmacy and Health Sciences, Forest Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT01605864
Brief Title
Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
Albany College of Pharmacy and Health Sciences, Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Bacterial Pneumonia
Keywords
pneumonia, community acquired bacterial pneumonia, CAP, CABP, bacterial pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efficacy of ceftaroline
Intervention Description
Determining the efficacy of ceftaroline compared to other cephalosporins
Primary Outcome Measure Information:
Title
Achieving clinical stability
Description
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.
Time Frame
day 2
Title
Achieving clinical stability
Description
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.
Time Frame
day 3
Title
Achieving clinical stability
Description
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.
Time Frame
day 4
Secondary Outcome Measure Information:
Title
Achieving clinical stability
Description
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.
Time Frame
day 5
Title
Hospital Readmission
Description
medical record review to note if subject re-admitted within past 30 days
Time Frame
day 30
Title
All-cause mortality
Description
medical record review to identify if subject mortality occured within past 30 days
Time Frame
day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Triner, DO, MPH
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Lodise, PharmD
Organizational Affiliation
Albany College of Pharmacy and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

We'll reach out to this number within 24 hrs