Whole Body Washing With Chlorhexidine for the Eradication of MRSA

December 15, 2005 updated by: Heidelberg University

The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA - a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial

The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.

Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.

Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg

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:

  • persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA

Exclusion Criteria:

  • ongoing systemic or local antimicrobial treatment directed against MRSA
  • hypersensitivity to mupirocin or chlorhexidine
  • pregnancy
  • previous enrolment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

Secondary Outcome Measures

Outcome Measure
development of MRSA infection
tolerance to the antiseptic whole body treatment

Collaborators and Investigators

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

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Constanze Wendt, MD, MSc, Hygiene-Institut University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2001

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2005

Last Update Submitted That Met QC Criteria

December 15, 2005

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94/2000
  • Projekt-Nr. 384/2000

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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