Whole Body Washing With Chlorhexidine for the Eradication of MRSA - Full Text View

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00266448

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Chlorhexidine Chlorhexidine digluconate Hibiclens

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	94/2000, Projekt-Nr. 384/2000
Study First Received:	December 15, 2005
Last Updated:	December 15, 2005
ClinicalTrials.gov Identifier:	NCT00266448 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

MRSA
eradication
chlorhexidine

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Chlorhexidine

Chlorhexidine gluconate
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010