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Completed

NCT Number: NCT00266448

Whole Body Washing With Chlorhexidine for the Eradication of MRSA

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Heidelberg

Heidelberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine solution 4%

Drug

Primary outcomes

  1. efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

Secondary outcomes

  1. development of MRSA infection

  2. tolerance to the antiseptic whole body treatment

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Dec 16, 2005
Registry last updated
Dec 16, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.