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Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232231
First Posted: November 2, 2010
Last Update Posted: February 15, 2013
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.
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Joseph Kim, University of Calgary
  Purpose
The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.

Condition Intervention
Methicillin-resistant Staphylococcus Aureus Drug: pharmacological decolonization treatment Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Joseph Kim, University of Calgary:

Primary Outcome Measures:
  • Eradication of MRSA carriage [ Time Frame: 90 days after randomization ]

Secondary Outcome Measures:
  • Occurrence of MRSA infection [ Time Frame: Within 6 months of randomization ]

Enrollment: 15
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: decolonization treatment
topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning
Drug: pharmacological decolonization treatment
Chlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days
education
No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning
Behavioral: Education
No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prior MRSA infection (i.e index case)
  • Identified as being colonized with MRSA on initial screen

Exclusion Criteria:

  • Are pregnant or breastfeeding.
  • Have indwelling catheters.
  • Received prior decolonization treatment within last 6 months of enrollment.
  • Have allergy to study medication.
  • Are colonized with MRSA strain resistant to study medication.
  • Have active infection requiring systemic antimicrobials.
  • Are household contacts to index case.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01232231


Locations
Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
Joseph Kim
Alberta Health Services
Investigators
Principal Investigator: Thomas J Louie, MD University of Calgary
  More Information

Responsible Party: Joseph Kim, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01232231     History of Changes
Other Study ID Numbers: E23134
First Submitted: November 1, 2010
First Posted: November 2, 2010
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Joseph Kim, University of Calgary:
methicillin-resistant Staphylococcus aureus
decolonization
random allocation
outpatient

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents