Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

NCT01605864 | Completed Phase 3

• 1 other identifier: 3216
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

pneumonia; community acquired bacterial pneumonia; CAP; CABP; bacterial pneumonia

Outcome Measures

Primary Outcomes (3)

• 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.

  day 2

• 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.

  day 3

• 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.

  day 4

Secondary Outcomes (3)

• Achieving clinical stability

  day 5

• Hospital Readmission

  day 30

• All-cause mortality

  day 30

Interventions

Efficacy of ceftaroline DRUG

Determining the efficacy of ceftaroline compared to other cephalosporins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• Albany College of Pharmacy and Health Sciences: collaborator
• Forest Laboratories: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12204, United States

Location

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Wayne Triner, DO, MPH

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Tom Lodise, PharmD

  Albany College of Pharmacy and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Research Director Dept.of Emergency Medicine

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 25, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 24, 2014

Record last verified: 2012-05

Locations

US (1)