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Whole Body Washing With Chlorhexidine for the Eradication of MRSA

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00266448
First received: December 15, 2005
Last updated: NA
Last verified: April 2004
History: No changes posted

December 15, 2005
December 15, 2005
January 2001
Not Provided
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage
Same as current
No Changes Posted
  • development of MRSA infection
  • tolerance to the antiseptic whole body treatment
Same as current
Not Provided
Not Provided
 
Whole Body Washing With Chlorhexidine for the Eradication of MRSA
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
MRSA-Colonization
Drug: Chlorhexidine solution 4%
Not Provided
Wendt C, Schinke S, Wurttemberger M, Oberdorfer K, Bock-Hensley O, von Baum H. Value of whole-body washing with chlorhexidine for the eradication of methicillin-resistant Staphylococcus aureus: a randomized, placebo-controlled, double-blind clinical trial. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1036-43. Epub 2007 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00266448
94/2000, Projekt-Nr. 384/2000
Not Provided
Not Provided
Heidelberg University
Not Provided
Principal Investigator: Constanze Wendt, MD, MSc Hygiene-Institut University Hospital Heidelberg
Heidelberg University
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP