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Whole Body Washing With Chlorhexidine for the Eradication of MRSA

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00266448
First received: December 15, 2005
Last updated: NA
Last verified: April 2004
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266448

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

No publications provided by University of Heidelberg

Additional 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
Study First Received: December 15, 2005
Last Updated: December 15, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
MRSA
eradication
chlorhexidine

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013