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

Not Applicable

Completed

• Conditions: Methicillin Resistant Staphylococcus Aureus Skin Infections
• Interventions: Drug: nasal mupirocin; Drug: topical 3% hexachlorophene body wash; Drug: oral anti-MRSA antibiotic

• Registration Number: NCT01049438
• Lead Sponsor: Natividad Medical Center

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Last Update Submitted: 2010-01-13
• Study First Posted: 2010-01-14
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal, body, and systemic decolonization	nasal mupirocin	-
Nasal, body, and systemic decolonization	topical 3% hexachlorophene body wash	-
Nasal, body, and systemic decolonization	oral anti-MRSA antibiotic	-

Primary Outcome Measures

Name	Time	Method
A new MRSA or skin infection consistent with MRSA infection.	6 months