Whole Body Washing With Chlorhexidine for the Eradication of MRSA

NCT ID: NCT00266448

Last Updated: 2005-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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MRSA-Colonization

Keywords

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MRSA eradication chlorhexidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Chlorhexidine solution 4%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Constanze Wendt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hygiene-Institut University Hospital Heidelberg

Locations

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University Hospital Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1086/519929. Epub 2007 Jul 3.

Reference Type DERIVED
PMID: 17932823 (View on PubMed)

Other Identifiers

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Projekt-Nr. 384/2000

Identifier Type: -

Identifier Source: secondary_id

94/2000

Identifier Type: -

Identifier Source: org_study_id