Whole Body Washing With Chlorhexidine for the Eradication... | NCT00266448

Studies
Whole Body Washing With Chlorhexidine for the Eradication of MRSA

NCT00266448

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Dec 16, 2005Estimated

Enrollment

100

Phase

Phase 2

Conditions

MRSA-Colonization

Interventions

Chlorhexidine solution 4%

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Projekt-Nr. 384/2000

Status Module

Record Verification Date

Apr 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Not provided

Completion Date

Apr 2004

First Submitted Date

Dec 15, 2005

First Submission Date that Met QC Criteria

Dec 15, 2005

First Posted Date

Dec 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2005

Last Update Posted Date

Dec 16, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Heidelberg UniversityOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine solution 4%	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

Secondary Outcomes

Measure	Description	Time Frame
development of MRSA infection
tolerance to the antiseptic whole body treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constanze Wendt, MD, MSc	Hygiene-Institut University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17932823	Derived	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.