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

This study has been completed.
Sponsor:
Information provided by:
Natividad Medical Center
ClinicalTrials.gov Identifier:
NCT01049438
First received: January 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 13, 2010
January 13, 2010
August 2006
September 2009   (final data collection date for primary outcome measure)
A new MRSA or skin infection consistent with MRSA infection. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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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
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Methicillin Resistant Staphylococcus Aureus Skin Infections
  • Drug: nasal mupirocin
    twice daily for 10 days
    Other Name: Bactrban Nasal
  • Drug: topical 3% hexachlorophene body wash
    daily for 10 days
    Other Name: Phisohex
  • Drug: 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
    Other Names:
    • trimethoprim-sulfamethoxazole
    • doxycycline
    • minocycline
Experimental: Nasal, body, and systemic decolonization
Interventions:
  • Drug: nasal mupirocin
  • Drug: topical 3% hexachlorophene body wash
  • Drug: oral anti-MRSA antibiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria: recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01049438
20020519
Yes
Allen Radner, MD, Navidad Medical Center
Natividad Medical Center
Not Provided
Principal Investigator: Allen Radner, M.D. Navidad Medical Center
Natividad Medical Center
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP