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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Horizon Health Network
Sponsor:
Information provided by (Responsible Party):
Duncan Webster, Horizon Health Network
ClinicalTrials.gov Identifier:
NCT01438515
First received: September 21, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention
Methicillin-resistant Staphylococcus Aureus
Drug: Rifampin
Drug: Doxycycline
Other: 2% mupirocin ointment
Other: 4% chlorhexidine gluconate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Horizon Health Network:

Primary Outcome Measures:
  • Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months [ Designated as safety issue: No ]
    To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.


Secondary Outcome Measures:
  • Changes in susceptibility patterns of MRSA isolates. [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438515

Contacts
Contact: Paula Duffley, RN 5066487098 Paula.Duffley@HorizonNB.ca

Locations
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L4L2
Contact: Paula Duffley, RN    5066487098      
Principal Investigator: Duncan Webster, MA, MD         
Sponsors and Collaborators
Horizon Health Network
Investigators
Principal Investigator: Duncan Webster, MA, MD Horizon Health Network
  More Information

Publications:
Responsible Party: Duncan Webster, Physician, Infectious Diseases and Medical Microbiology, Horizon Health Network
ClinicalTrials.gov Identifier: NCT01438515     History of Changes
Other Study ID Numbers: 2008-1265
Study First Received: September 21, 2011
Last Updated: August 28, 2013
Health Authority: Canada: Health Canada
United States: Federal Government

Keywords provided by Horizon Health Network:
MRSA
doxycycline
rifampin
mupirocin
chlorhexidine gluconate
decolonization
methicillin-resistant staphylococcus aureus

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Doxycycline hyclate
Doxycycline
Methicillin
Rifampin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014