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A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections

Primary Purpose

Skin Diseases, Bacterial

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 Skin Diseases, Bacterial focused on measuring skin infection, bacterial infection, levofloxacin, quinolones, skin, infection

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of bacterial skin and skin structure infection with a complicating factor, (including a pre-existing skin lesion, or a condition affecting the way the drug gets to the infected area of the body, the body's disease defense (immune) system, or the ability of tissues to heal properly) have at least 2 of the following signs and symptoms of skin infection: pain, redness, swelling, hardness, pus formation have an infection of one of the following types: wound infections (crush, puncture, cut, gunshot, surgery, bite), infected skin ulcers, or infections in patients with decreased immune system function (HIV infections, diabetes, etc) able to provide a sample of tissue from the affected area of the skin Exclusion Criteria: Patients with multiple infected ulcers at separate locations on body requiring immediate surgery at the infection site having low blood pressure, decreased urination, decreased kidney function, seizure disorder, unstable mental disorder, low white blood cell count, bone infection, shock, or are HIV positive having an infection from a bacteria known to be resistant to any of the study drugs having a previous allergic or serious reaction to any of the study drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical response rates at post-therapy, categorized as cured, improved, or failed.

    Secondary Outcome Measures

    Rate of elimination of disease-causing bacteria post-study, by patient, and by bacteria type; Clinical relapse and new infection rates based upon signs and symptoms at post-study; Microbiologic relapse rates

    Full Information

    First Posted
    November 4, 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
    NCT00249197
    Brief Title
    A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections
    Official Title
    A Multicenter, Randomized, Open-Label Study to Compare the Safety and Efficacy of i.v. And/Or Oral Levofloxacin With That of Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Bacterial Skin and Skin Structure Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 1998 (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 compare the safety and effectiveness of levofloxacin (an antibiotic) with ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of complicated skin infections.
    Detailed Description
    Levofloxacin is an antibiotic that has been evaluated in clinical trials for use in the treatment of many types of infections including respiratory tract, urinary tract, and uncomplicated skin infections. Levofloxacin may be taken by mouth or administered slowly through a vein and has been shown to be safe and effective when administered once daily. This multicenter, open-label study will evaluate the safety and effectiveness of a single daily oral or intravenous dose of levofloxacin compared to multiple daily intravenous doses with another antibiotic, ticarcillin/clavulanate given alone or followed by oral amoxicillin/clavulanate, in the treatment of bacterial skin infections. Patients will receive 750 mg of levofloxacin by mouth or intravenously for 7 - 14 days, or 3.1 grams of ticarcillin/clavulanate intravenously for 7 - 14 days. Patients receiving levofloxacin intravenously may be switched to receive levofloxacin by mouth; patients receiving ticarcillin/clavulanate intravenously may be switched to 875 mg of amoxicillin/clavulanate given by mouth, twice daily, if significant improvement is noted. Patients are assessed after 3 - 4 days of treatment; treatment is discontinued if no significant improvement is noted. Patients showing signs of improvement continue in the study, with assessments 2 - 5 days (post-therapy visit) and 3 - 4 weeks (post-study visit) after completion of the study drug. The primary measure of effectiveness is the clinical response rate assessed 2 - 5 days after the last dose of antibiotic treatment, categorizing the response as cured, improved, or failed. Laboratory tests for the presence of bacteria are performed throughout the study. Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. The study hypothesis is that a single daily dose of levofloxacin is at least as effective as multiple daily doses of ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of skin infections, and that it is well tolerated. Levofloxacin 750 mg intravenously or by mouth, once daily for 7 - 14 days, or ticarcillin/clavulanate 3.1 grams intravenously every 4 - 6 hours, may be switched to amoxicillin/clavulanate 875 mg by mouth, twice daily, total duration 7 - 14 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Diseases, Bacterial
    Keywords
    skin infection, bacterial infection, levofloxacin, quinolones, skin, infection

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levofloxacin
    Primary Outcome Measure Information:
    Title
    Clinical response rates at post-therapy, categorized as cured, improved, or failed.
    Secondary Outcome Measure Information:
    Title
    Rate of elimination of disease-causing bacteria post-study, by patient, and by bacteria type; Clinical relapse and new infection rates based upon signs and symptoms at post-study; Microbiologic relapse rates

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of bacterial skin and skin structure infection with a complicating factor, (including a pre-existing skin lesion, or a condition affecting the way the drug gets to the infected area of the body, the body's disease defense (immune) system, or the ability of tissues to heal properly) have at least 2 of the following signs and symptoms of skin infection: pain, redness, swelling, hardness, pus formation have an infection of one of the following types: wound infections (crush, puncture, cut, gunshot, surgery, bite), infected skin ulcers, or infections in patients with decreased immune system function (HIV infections, diabetes, etc) able to provide a sample of tissue from the affected area of the skin Exclusion Criteria: Patients with multiple infected ulcers at separate locations on body requiring immediate surgery at the infection site having low blood pressure, decreased urination, decreased kidney function, seizure disorder, unstable mental disorder, low white blood cell count, bone infection, shock, or are HIV positive having an infection from a bacteria known to be resistant to any of the study drugs having a previous allergic or serious reaction to any of the study drugs
    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

    Citations:
    PubMed Identifier
    12145720
    Citation
    Graham DR, Talan DA, Nichols RL, Lucasti C, Corrado M, Morgan N, Fowler CL. Once-daily, high-dose levofloxacin versus ticarcillin-clavulanate alone or followed by amoxicillin-clavulanate for complicated skin and skin-structure infections: a randomized, open-label trial. Clin Infect Dis. 2002 Aug 15;35(4):381-9. doi: 10.1086/341026. Epub 2002 Jul 19.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=650&filename=CR005473_CSR.pdf
    Description
    A study of the safety and effectiveness of levofloxacin compared to ticarcillin/clavulanate alone or followed by amoxicillin/clavulanate in the treatment of skin infections

    Learn more about this trial

    A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections

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