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Completed

NCT Number: NCT01605864

Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia

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.

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Key information

Conditions

Community Acquired Bacterial Pneumonia Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Albany Medical Center

Albany, New York, 12204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efficacy of ceftaroline

Drug

Determining the efficacy of ceftaroline compared to other cephalosporins

Primary outcomes

  1. Achieving clinical stability

    Time frame: 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.

  2. Achieving clinical stability

    Time frame: 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.

  3. Achieving clinical stability

    Time frame: 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 outcomes

  1. Achieving clinical stability

    Time frame: 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.

  2. Hospital Readmission

    Time frame: day 30

    medical record review to note if subject re-admitted within past 30 days

  3. All-cause mortality

    Time frame: day 30

    medical record review to identify if subject mortality occured within past 30 days

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

  • Albany College of Pharmacy and Health Sciences
  • Forest Laboratories

Registry information

Official study title

Ceftaroline Fosamil Versus Standard of Care for Community Acquired Bacterial Pneumonia (CABP): Clinical Outcomes Among Hospitalized Adults at a Single United States Hospital

Acronym: CAP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 25, 2012
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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