Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia (CAP)
This study is currently recruiting participants.
Verified May 2012 by Albany Medical College
Sponsor:
Albany Medical College
Collaborators:
Albany College of Pharmacy and Health Sciences
Forest Laboratories
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College
ClinicalTrials.gov Identifier:
NCT01605864
First received: May 16, 2012
Last updated: May 23, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Community Acquired Bacterial Pneumonia |
Drug: Efficacy of ceftaroline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Albany Medical College:
Primary Outcome Measures:
- Achieving clinical stability [ Time Frame: day 2 ] [ Designated as safety issue: No ]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 [ Time Frame: day 3 ] [ Designated as safety issue: No ]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 [ Time Frame: day 4 ] [ Designated as safety issue: No ]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 [ Time Frame: day 5 ] [ Designated as safety issue: No ]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 [ Time Frame: day 30 ] [ Designated as safety issue: No ]medical record review to note if subject re-admitted within past 30 days
- All-cause mortality [ Time Frame: day 30 ] [ Designated as safety issue: No ]medical record review to identify if subject mortality occured within past 30 days
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Efficacy of ceftaroline
Determining the efficacy of ceftaroline compared to other cephalosporins
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605864
Contacts
| Contact: Wayne Triner, DO, MPH | 518-262-3773 | TrinerW@mail.amc.edu |
| Contact: Tom Lodise, PharmD | 518-694-7292 | tom.lodise@acphs.edu |
Locations
| United States, New York | |
| Albany Medical Center | Recruiting |
| Albany, New York, United States, 12204 | |
| Contact: Wayne Triner, DO, MPH 518-262-3773 TrinerW@mail.amc.edu | |
| Contact: Nancy Robak, RN, MPH 518-262-3773 RobakN@mail.amc.edu | |
| Principal Investigator: Wayne Triner, DO, MPH | |
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 |
More Information
No publications provided
| Responsible Party: | Wayne Triner, Professor and Research Director Dept.of Emergency Medicine, Albany Medical College |
| ClinicalTrials.gov Identifier: | NCT01605864 History of Changes |
| Other Study ID Numbers: | 3216 |
| Study First Received: | May 16, 2012 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Albany Medical College:
|
pneumonia community acquired bacterial pneumonia CAP CABP bacterial pneumonia |
Additional relevant MeSH terms:
|
Pneumonia, Bacterial Pneumonia Bacterial Infections |
Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 19, 2013