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Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx (SJMRSA)

Primary Purpose

Methicillin-Resistant Staphylococcus Aureus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Theraworx
mupirocin antibiotic ointment
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Methicillin-Resistant Staphylococcus Aureus focused on measuring Methicillin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Positive MRSA culture

Exclusion Criteria:

  • Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
  • Patients with MRSA infected wounds
  • Patients under the age of 18 years
  • A woman currently pregnant or nursing a child
  • Patients participating in another study within 30 days of randomization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    No Treatment

    Theraworx intranasal

    mupirocin antibiotic ointment intranasal

    Outcomes

    Primary Outcome Measures

    Evidence of decolonization confirmed by intranasal culture

    Secondary Outcome Measures

    Economic-Cost comparison of treatment Evidence of decolonization

    Full Information

    First Posted
    July 7, 2008
    Last Updated
    March 21, 2017
    Sponsor
    Mercy Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00713674
    Brief Title
    Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx
    Acronym
    SJMRSA
    Official Title
    Comparison of Decolonization of MRSA Using Theraworx
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of patient recruitment.
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mercy Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.
    Detailed Description
    Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Methicillin-Resistant Staphylococcus Aureus
    Keywords
    Methicillin resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    No Intervention
    Arm Description
    No Treatment
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Theraworx intranasal
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    mupirocin antibiotic ointment intranasal
    Intervention Type
    Other
    Intervention Name(s)
    Theraworx
    Intervention Description
    Theraworx swab intranasal BID for 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    mupirocin antibiotic ointment
    Intervention Description
    mupirocin antibiotic ointment swab intranasal BID for 5 days
    Primary Outcome Measure Information:
    Title
    Evidence of decolonization confirmed by intranasal culture
    Time Frame
    Up to 14 days post treatment (+/- 1-2 days)
    Secondary Outcome Measure Information:
    Title
    Economic-Cost comparison of treatment Evidence of decolonization
    Time Frame
    5 days of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Positive MRSA culture Exclusion Criteria: Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.) Patients with MRSA infected wounds Patients under the age of 18 years A woman currently pregnant or nursing a child Patients participating in another study within 30 days of randomization
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roger E Huckfeldt, MD
    Organizational Affiliation
    Mercy/St. John's Hospital - Springfield
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx

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