Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

NCT ID: NCT01605864

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Community Acquired Bacterial Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Efficacy of ceftaroline

Determining the efficacy of ceftaroline compared to other cephalosporins

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany College of Pharmacy and Health Sciences

OTHER

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Wayne Triner

Professor and Research Director Dept.of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Triner, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Tom Lodise, PharmD

Role: PRINCIPAL_INVESTIGATOR

Albany College of Pharmacy and Health Sciences

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

Other Identifiers

3216

Identifier Type: -

Identifier Source: org_study_id