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
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
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
NCT ID
NCT01049438
First Posted
January 13, 2010
Last Updated
January 13, 2010
Sponsor
Natividad Medical Center
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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