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Whole Body Washing With Chlorhexidine for the Eradication of MRSA

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266448
First Posted: December 16, 2005
Last Update Posted: December 16, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
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).

Condition Intervention Phase
MRSA-Colonization Drug: Chlorhexidine solution 4% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA – a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

Secondary Outcome Measures:
  • development of MRSA infection
  • tolerance to the antiseptic whole body treatment

Estimated Enrollment: 100
Study Start Date: January 2001
Estimated Study Completion Date: April 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266448


Locations
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Constanze Wendt, MD, MSc Hygiene-Institut University Hospital Heidelberg
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00266448     History of Changes
Other Study ID Numbers: 94/2000
Projekt-Nr. 384/2000
First Submitted: December 15, 2005
First Posted: December 16, 2005
Last Update Posted: December 16, 2005
Last Verified: April 2004

Keywords provided by Heidelberg University:
MRSA
eradication
chlorhexidine

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents