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

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232231
• Other study ID #: E23134
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: February 14, 2013
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

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

Behavioral:
• Education
No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Kim	Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of MRSA carriage		90 days after randomization	No
Secondary	Occurrence of MRSA infection		Within 6 months of randomization	No