Whole Body Washing With Chlorhexidine for the Eradication of MRSA

MRSA-Colonization Clinical Trial

Official title:

The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA – a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266448
• Other study ID #: 94/2000
• Secondary ID: Projekt-Nr. 384/
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2005
• Last updated: December 15, 2005
• Start date: January 2001
• Est. completion date: April 2004

Study information

• Verified date: April 2004
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• MRSA-Colonization

Intervention

Drug:
• Chlorhexidine solution 4%

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage
Secondary	development of MRSA infection
Secondary	tolerance to the antiseptic whole body treatment