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A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections

Primary Purpose

Methicillin Resistant Staphylococcus Aureus Skin Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nasal mupirocin
topical 3% hexachlorophene body wash
oral anti-MRSA antibiotic
Sponsored by
Natividad Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Methicillin Resistant Staphylococcus Aureus Skin Infections focused on measuring MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Inclusion Criteria: recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Nasal, body, and systemic decolonization

    Arm Description

    Outcomes

    Primary Outcome Measures

    A new MRSA or skin infection consistent with MRSA infection.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2010
    Last Updated
    January 13, 2010
    Sponsor
    Natividad Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01049438
    Brief Title
    A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
    Official Title
    A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Natividad Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.
    Detailed Description
    Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S. CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. However, there are no data that quantify the efficacy and safety of this approach. We conducted a prospective non-comparative clinical trial to quantify the efficacy and safety of body decolonization regimens in the prevention of CA-MRSA infection from an Infectious Diseases private practice group in Northern California. The study population comprised of persons suffering from recurrent CA-MRSA infection. For this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient. Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months using a standardized questionnaire. The baseline survey, based on a previously developed instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and health-related quality of life. Follow up surveys asked about adverse drug effects, especially gastrointestinal and dermatologic side effects (2 week visit only) and incident skin and MRSA infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Methicillin Resistant Staphylococcus Aureus Skin Infections
    Keywords
    MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nasal, body, and systemic decolonization
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    nasal mupirocin
    Other Intervention Name(s)
    Bactrban Nasal
    Intervention Description
    twice daily for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    topical 3% hexachlorophene body wash
    Other Intervention Name(s)
    Phisohex
    Intervention Description
    daily for 10 days
    Intervention Type
    Drug
    Intervention Name(s)
    oral anti-MRSA antibiotic
    Other Intervention Name(s)
    trimethoprim-sulfamethoxazole, doxycycline, minocycline
    Intervention Description
    The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient
    Primary Outcome Measure Information:
    Title
    A new MRSA or skin infection consistent with MRSA infection.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allen Radner, M.D.
    Organizational Affiliation
    Navidad Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections

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