CAP: Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

Sponsor

Albany Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT01605864

Collaborator

Albany College of Pharmacy and Health Sciences (Other), Forest Laboratories (Industry)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Bacterial Pneumonia	Drug: Efficacy of ceftaroline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Outcome Measures

Primary Outcome Measures

Achieving clinical stability [day 2]
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 [day 3]
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 [day 4]
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 [day 5]
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 [day 30]
medical record review to note if subject re-admitted within past 30 days
All-cause mortality [day 30]
medical record review to identify if subject mortality occured within past 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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