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A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin

Primary Purpose

Skin Diseases, Infectious, Cellulitis

Status
Completed
Phase
Phase 2
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 Skin Diseases, Infectious focused on measuring Infectious skin diseases, skin diseases, bacterial skin diseases, cellulitis, quinolones, levofloxacin

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of mild to moderate infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, drainage, swelling, or other relevant clinical signs tissue sample available from the area of the skin affected by the bacteria able to take medication by mouth Exclusion Criteria: Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin having a severe infection previous allergic or serious adverse reactions to similar antibiotics taken antibiotics internally within 48 hours of the start of the study with resulting improvement require a second antibiotic taken internally or need an antibiotic applied directly to the site of the infection in addition to the study drug

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical response rate (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events.

    Secondary Outcome Measures

    Change in physical examination and in laboratory tests after treatment with the study drug.

    Full Information

    First Posted
    November 18, 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
    NCT00257036
    Brief Title
    A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin
    Official Title
    A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Levofloxacin Versus Ciprofloxacin HCl in the Treatment of Mild to Moderate Skin and Skin Structure Infections in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 1993 (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 safety and effectiveness of levofloxacin, an antibiotic, compared with ciprofloxacin, another antibiotic, in the treatment of adults with mild to moderate infections of the skin and the supportive layers beneath the skin.
    Detailed Description
    Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (500 mg by mouth once daily for 7-10 days) compared with another frequently used antibiotic, ciprofloxacin (500 mg by mouth every 12 hours for 7 -10 days), in adults with mild to moderate infections of the skin and the supportive layers beneath the skin. The study consists of 3 visits: one visit [pre-therapy] for screening and enrollment, and two visits to assess safety and effectiveness (one visit [on-therapy] on Days 3 - 5 of the study and one visit [post-therapy] 2 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary assessments of effectiveness include the clinical response to treatment (defined at post-therapy as cured, improved or failed) and the microbiological response at post-therapy (the rate of eradication of the disease-causing bacteria, determined by patient and by type of bacteria). Safety evaluations (incidence of adverse events, physical examination, physical examination of the skin, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with ciprofloxacin in patients with mild to moderate infections of the skin and the supportive layers beneath the skin. Levofloxacin 500 mg by mouth once daily, or ciprofloxacin 500 mg by mouth every 12 hours. The duration of treatment is 7 to 10 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Infectious, Cellulitis
    Keywords
    Infectious skin diseases, skin diseases, bacterial skin diseases, cellulitis, quinolones, levofloxacin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    431 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levofloxacin
    Primary Outcome Measure Information:
    Title
    Clinical response rate (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events.
    Secondary Outcome Measure Information:
    Title
    Change in physical examination and in laboratory tests after treatment with the study drug.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of mild to moderate infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, drainage, swelling, or other relevant clinical signs tissue sample available from the area of the skin affected by the bacteria able to take medication by mouth Exclusion Criteria: Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin having a severe infection previous allergic or serious adverse reactions to similar antibiotics taken antibiotics internally within 48 hours of the start of the study with resulting improvement require a second antibiotic taken internally or need an antibiotic applied directly to the site of the infection in addition to the study drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & 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

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=651&filename=CR005476_CSR.pdf
    Description
    A study of the safety and effectiveness of oral levofloxacin compared with oral ciprofloxacin in the treatment of adults with mild to moderate infections of the skin and the supportive layers beneath the skin

    Learn more about this trial

    A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin

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