Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
NCT ID: NCT01438515
Last Updated: 2020-02-17
Study Results
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-08-31
2019-12-31
Brief Summary
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Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Systemic decolonization
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
Rifampin
600mg po once daily x 7 days
Doxycycline
100mg po twice daily x 7 days
2% mupirocin ointment
\~ 1cm applied to the anterior nares twice daily for 7 days
4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days
Standard decolonization
7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
2% mupirocin ointment
\~ 1cm applied to the anterior nares twice daily for 7 days
4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days
Interventions
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Rifampin
600mg po once daily x 7 days
Doxycycline
100mg po twice daily x 7 days
2% mupirocin ointment
\~ 1cm applied to the anterior nares twice daily for 7 days
4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or breastfeeding women
* Active infection
* Hepatic cirrhosis or abnormal INR due to liver disease
* Decolonization in the previous two (2) months
* MRSA bacteria resistant to one or more of the study medications
* AST and ALT levels more than five times the upper limit of normal.
18 Years
ALL
No
Sponsors
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Horizon Health Network
OTHER
Responsible Party
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Duncan Webster
Physician, Infectious Diseases and Medical Microbiology
Principal Investigators
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Duncan Webster, MA, MD
Role: PRINCIPAL_INVESTIGATOR
Horizon Health Network
Locations
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Saint John Regional Hospital
Saint John, New Brunswick, Canada
Countries
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References
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Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. doi: 10.1086/510392. Epub 2006 Dec 14.
Other Identifiers
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2008-1265
Identifier Type: -
Identifier Source: org_study_id
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