Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

NCT01438515 | Completed

• 1 other identifier: 2008-1265
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methicillin-resistant Staphylococcus Aureus

Keywords

MRSA; doxycycline; rifampin; mupirocin; chlorhexidine gluconate; decolonization; methicillin-resistant staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months

  To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.

  12 months

Secondary Outcomes (1)

• Changes in susceptibility patterns of MRSA isolates.

  12 months

Study Arms (2)

Systemic decolonization

EXPERIMENTAL

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)

Drug: Rifampin; Drug: Doxycycline; Other: 2% mupirocin ointment; Other: 4% chlorhexidine gluconate

Standard decolonization

ACTIVE COMPARATOR

7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.

Other: 2% mupirocin ointment; Other: 4% chlorhexidine gluconate

Interventions

Rifampin DRUG

600mg po once daily x 7 days

Systemic decolonization

Doxycycline DRUG

100mg po twice daily x 7 days

Systemic decolonization

2% mupirocin ointment OTHER

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

Standard decolonization; Systemic decolonization

4% chlorhexidine gluconate OTHER

Daily full body wash (including hair) for 7 days

Standard decolonization; Systemic decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient colonized with MRSA

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horizon Health Network: lead

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L4L2, Canada

Location

Related Publications (1)

• 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.

  PMID: 17173213 BACKGROUND

MeSH Terms

Interventions

Rifampin; Doxycycline; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Duncan Webster, MA, MD

  Horizon Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Infectious Diseases and Medical Microbiology

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 22, 2011
• Study Start: August 1, 2008
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CA (1)