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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438515
Recruitment Status : Active, not recruiting
First Posted : September 22, 2011
Last Update Posted : August 28, 2018
Information provided by (Responsible Party):
Duncan Webster, Horizon Health Network

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.

Condition or disease Intervention/treatment Phase
Methicillin-resistant Staphylococcus Aureus Drug: Rifampin Drug: Doxycycline Other: 2% mupirocin ointment Other: 4% chlorhexidine gluconate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population
Study Start Date : August 2008
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arm Intervention/treatment
Experimental: 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)
Drug: Rifampin
600mg po once daily x 7 days

Drug: Doxycycline
100mg po twice daily x 7 days

Other: 2% mupirocin ointment
~ 1cm applied to the anterior nares twice daily for 7 days

Other: 4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days

Active Comparator: Standard decolonization
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
~ 1cm applied to the anterior nares twice daily for 7 days

Other: 4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days

Primary Outcome Measures :
  1. Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months [ Time Frame: 12 months ]
    To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.

Secondary Outcome Measures :
  1. Changes in susceptibility patterns of MRSA isolates. [ Time Frame: 12 months ]
    Study isolates will be evaluated with regards to mupirocin, rifampin and tetracycline resistance patterns, where individuals remain colonized, or re-colonize subsequent to implementation of the decolonization protocol.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438515

Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L4L2
Sponsors and Collaborators
Horizon Health Network
Principal Investigator: Duncan Webster, MA, MD Horizon Health Network

Responsible Party: Duncan Webster, Physician, Infectious Diseases and Medical Microbiology, Horizon Health Network Identifier: NCT01438515     History of Changes
Other Study ID Numbers: 2008-1265
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Duncan Webster, Horizon Health Network:
chlorhexidine gluconate
methicillin-resistant staphylococcus aureus

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Protein Synthesis Inhibitors