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

This study has been completed.
Sponsor:
Collaborator:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Joseph Kim, University of Calgary
ClinicalTrials.gov Identifier:
NCT01232231
First received: November 1, 2010
Last updated: February 14, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Calgary:

Primary Outcome Measures:
  • Eradication of MRSA carriage [ Time Frame: 90 days after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of MRSA infection [ Time Frame: Within 6 months of randomization ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232231

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

No publications provided

Responsible Party: Joseph Kim, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01232231     History of Changes
Other Study ID Numbers: E23134
Study First Received: November 1, 2010
Last Updated: February 14, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014