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

• Sponsor: Joseph Kim (Other)
• Overall Status: Completed
• CT.gov ID: NCT01232231
• Collaborator: Alberta Health services (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 28.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Methicillin-resistant Staphylococcus Aureus	Drug: pharmacological decolonization treatment; Behavioral: Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• 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
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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
Other: 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

Outcome Measures

Primary Outcome Measures

1. Eradication of MRSA carriage [90 days after randomization]

Secondary Outcome Measures

1. Occurrence of MRSA infection [Within 6 months of randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

• Keywords provided by Joseph Kim, Clinical Assistant Professor, University of Calgary: methicillin-resistant Staphylococcus aureus; decolonization; random allocation; outpatient
• Additional relevant MeSH terms: Staphylococcal Infections

Study Results

No Results Posted as of Feb 15, 2013