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

January 13, 2010 updated by: Natividad Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nasal, body, and systemic decolonization
Drug: nasal mupirocin
twice daily for 10 days
Other Names:
  • Bactrban Nasal
Drug: topical 3% hexachlorophene body wash
daily for 10 days
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A new MRSA or skin infection consistent with MRSA infection.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natividad Medical Center

Investigators

  • Principal Investigator: Allen Radner, M.D., Navidad Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (ESTIMATE)

January 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 13, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020519

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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