Whole Body Washing With Chlorhexidine for the Eradication of MRSA

Phase 2

Completed

• Conditions: MRSA-Colonization

• Registration Number: NCT00266448
• Lead Sponsor: Heidelberg University

Brief 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).

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.

Study Timeline

• Study Start: 2001-01
• Status Verified: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Last Update Submitted: 2005-12-15
• Study First Posted: 2005-12-16
• Last Update Posted: 2005-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

Secondary Outcome Measures

Name	Time	Method
development of MRSA infection
tolerance to the antiseptic whole body treatment

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany