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A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
levofloxacin
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring respiratory tract diseases, pneumonia, levofloxacin, community-acquired pneumonia, lung diseases, quinolones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of community-acquired pneumonia as follows: clinical signs and symptoms of a lower respiratory tract infection and chest-x-ray findings consistent with pneumonia within 24 hours before entry into the study At least one of the following: abnormal temperature (high or low) or abnormal white blood cell count Previous antibiotic treatment <= 24 hours or, if the duration of treatment was >= 72 hours and that therapy failed based on at least 2 of the following: fever within 12 hours of entry into the study, chest x-ray findings have worsened compared to the initial chest-x-ray, white blood cell count is significantly increased, respiratory rate higher than at the start of treatment and >= 20 breaths per minute or need for supplemental oxygen if not previously needed Patients whose infection is acquired in the community or, if in a nursing home, who had been living there < 14 days Fine Class (rating scale used to assess patients' overall condition which includes information such as age, gender, other diseases, physical examination and laboratory findings) score <= 130 upon admission (patients with Fine Class scores > 70 but < = 130 must initially be hospitalized Patients with scores of <= 70 may be treated as outpatients or hospitalized at the discretion of the investigator) Exclusion Criteria: Pneumonia known or suspected to be due to a bacteria resistant to levofloxacin Previous allergic or serious reaction to or failed therapy with levofloxacin or similar drugs Life expectancy < 72 hours Hospitalized within 2 weeks before entry in the study or within 1 month before entry in the study if treated with antibiotics Pneumonia acquired in a hospital Cystic fibrosis or other lung disorders Receiving chronic steroid treatment Received assistance from a machine to breathe within the previous month

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical response rates based on signs and symptoms at posttherapy visit.

    Secondary Outcome Measures

    Microbiologic eradication rates at posttherapy visit; Clinical response rates (chest x-ray findings and signs/symptoms) and microbiologic eradication rates at poststudy; Incidence of adverse events

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236821
    Brief Title
    A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia
    Official Title
    Multicenter, Double-Blind Randomized Study to Compare the Safety and Efficacy of Levofloxacin 750 mg Once Daily for Five Days vs. Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Mild to Severe Community-Acquired Pneumonia in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily.
    Detailed Description
    Levofloxacin is an antibiotic that is approved by the FDA for the treatment of sinusitis, chronic bronchitis, skin infections, urinary tract infections, and community-acquired pneumonia. This multicenter, double-blind (neither the patient nor the study doctor will know the dose of levofloxacin being administered) study evaluates the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily. Patients receive levofloxacin by mouth or through a vein depending on the severity of their pneumonia. Patients are assessed after 3 days of treatment; treatment is discontinued if no significant improvement is noted. Patients showing signs of improvement continue in the study, with assessments on study days 12-16, and 17-21 (posttherapy visits), and 31-38 (poststudy visit). Effectiveness is assessed by measuring the ability of the study drug to eliminate bacteria causing pneumonia and to reduce the signs and symptoms of pneumonia. Chest x-rays and laboratory tests for presence of bacteria are performed during the study. Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. The study hypothesis is that levofloxacin administered at a higher dose for a shorter duration is at least as effective as levofloxacin administered at a lower dose for a longer duration in the treatment of community-acquired pneumonia and is generally well-tolerated. Levofloxacin, 500 milligrams (mg) by mouth or through vein daily for 10 days or 750 mg by mouth or slowly through a vein daily for 5 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia
    Keywords
    respiratory tract diseases, pneumonia, levofloxacin, community-acquired pneumonia, lung diseases, quinolones

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    530 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levofloxacin
    Primary Outcome Measure Information:
    Title
    Clinical response rates based on signs and symptoms at posttherapy visit.
    Secondary Outcome Measure Information:
    Title
    Microbiologic eradication rates at posttherapy visit; Clinical response rates (chest x-ray findings and signs/symptoms) and microbiologic eradication rates at poststudy; Incidence of adverse events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of community-acquired pneumonia as follows: clinical signs and symptoms of a lower respiratory tract infection and chest-x-ray findings consistent with pneumonia within 24 hours before entry into the study At least one of the following: abnormal temperature (high or low) or abnormal white blood cell count Previous antibiotic treatment <= 24 hours or, if the duration of treatment was >= 72 hours and that therapy failed based on at least 2 of the following: fever within 12 hours of entry into the study, chest x-ray findings have worsened compared to the initial chest-x-ray, white blood cell count is significantly increased, respiratory rate higher than at the start of treatment and >= 20 breaths per minute or need for supplemental oxygen if not previously needed Patients whose infection is acquired in the community or, if in a nursing home, who had been living there < 14 days Fine Class (rating scale used to assess patients' overall condition which includes information such as age, gender, other diseases, physical examination and laboratory findings) score <= 130 upon admission (patients with Fine Class scores > 70 but < = 130 must initially be hospitalized Patients with scores of <= 70 may be treated as outpatients or hospitalized at the discretion of the investigator) Exclusion Criteria: Pneumonia known or suspected to be due to a bacteria resistant to levofloxacin Previous allergic or serious reaction to or failed therapy with levofloxacin or similar drugs Life expectancy < 72 hours Hospitalized within 2 weeks before entry in the study or within 1 month before entry in the study if treated with antibiotics Pneumonia acquired in a hospital Cystic fibrosis or other lung disorders Receiving chronic steroid treatment Received assistance from a machine to breathe within the previous month
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12955634
    Citation
    Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003 Sep 15;37(6):752-60. doi: 10.1086/377539. Epub 2003 Aug 28. Erratum In: Clin Infect Dis. 2003 Oct 15;37(8):1147.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=663&filename=CR005554_CSR.pdf
    Description
    A study to compare the safety and effectiveness of 2 doses of levofloxacin given for different time periods in patients with pneumonia

    Learn more about this trial

    A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

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