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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2019-12-31

Brief Summary

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MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.

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.

Detailed Description

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Conditions

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Methicillin-resistant Staphylococcus Aureus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type EXPERIMENTAL

Rifampin

Intervention Type DRUG

600mg po once daily x 7 days

Doxycycline

Intervention Type DRUG

100mg po twice daily x 7 days

2% mupirocin ointment

Intervention Type OTHER

\~ 1cm applied to the anterior nares twice daily for 7 days

4% chlorhexidine gluconate

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

2% mupirocin ointment

Intervention Type OTHER

\~ 1cm applied to the anterior nares twice daily for 7 days

4% chlorhexidine gluconate

Intervention Type OTHER

Daily full body wash (including hair) for 7 days

Interventions

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Rifampin

600mg po once daily x 7 days

Intervention Type DRUG

Doxycycline

100mg po twice daily x 7 days

Intervention Type DRUG

2% mupirocin ointment

\~ 1cm applied to the anterior nares twice daily for 7 days

Intervention Type OTHER

4% chlorhexidine gluconate

Daily full body wash (including hair) for 7 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any patient colonized with MRSA

Exclusion Criteria

* Currently on treatment with antibiotics
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horizon Health Network

OTHER

Sponsor Role lead

Responsible Party

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Duncan Webster

Physician, Infectious Diseases and Medical Microbiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Canada

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.

Reference Type BACKGROUND
PMID: 17173213 (View on PubMed)

Other Identifiers

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2008-1265

Identifier Type: -

Identifier Source: org_study_id

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