NCT01232231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

November 1, 2010

Last Update Submit

February 14, 2013

Conditions

Keywords

methicillin-resistant Staphylococcus aureusdecolonizationrandom allocationoutpatient

Outcome Measures

Primary Outcomes (1)

  • Eradication of MRSA carriage

    90 days after randomization

Secondary Outcomes (1)

  • Occurrence of MRSA infection

    Within 6 months of randomization

Study Arms (2)

decolonization treatment

ACTIVE COMPARATOR

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

education

OTHER

No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning

Behavioral: Education

Interventions

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

decolonization treatment
EducationBEHAVIORAL

No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning

education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Thomas J Louie, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations