Individualized vs. Household MRSA Decolonization

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-11-28

Brief Summary

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The purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent Staphylococcus aureus skin infections. The investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent SSTI.

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Detailed Description

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Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).

There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).

Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.

Conditions

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Staphylococcal Skin Infection Abscess Furunculosis Staphylococcus Aureus MRSA Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Individualized Approach

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

Group Type ACTIVE_COMPARATOR

2% mupirocin ointment

Intervention Type DRUG

Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute)

Intervention Type OTHER

Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol

Intervention Type BEHAVIORAL

Follow key hygiene tips:

* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour or pump) soaps instead of bar soaps.
* Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
* Do not share personal care items such as razors, brushes, or deodorant.
* Wash all sheets and towels in hot water. Wash sheets every week.
* Use towels and wash cloths only once before washing and do not share.

Household Approach

All members of the household will perform the decolonization regimen.

Group Type ACTIVE_COMPARATOR

2% mupirocin ointment

Intervention Type DRUG

Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute)

Intervention Type OTHER

Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol

Intervention Type BEHAVIORAL

Follow key hygiene tips:

* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour or pump) soaps instead of bar soaps.
* Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
* Do not share personal care items such as razors, brushes, or deodorant.
* Wash all sheets and towels in hot water. Wash sheets every week.
* Use towels and wash cloths only once before washing and do not share.

Interventions

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2% mupirocin ointment

Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Intervention Type DRUG

Bleach Bath (dilute)

Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Intervention Type OTHER

Hygiene Protocol

Follow key hygiene tips:

* Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
* Use liquid(pour or pump) soaps instead of bar soaps.
* Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
* Do not share personal care items such as razors, brushes, or deodorant.
* Wash all sheets and towels in hot water. Wash sheets every week.
* Use towels and wash cloths only once before washing and do not share.

Intervention Type BEHAVIORAL

Other Intervention Names

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Bactroban Clorox

Eligibility Criteria

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Inclusion Criteria

* Individuals who are enrolled in a 12-month observational study entitled "The Community-Associated Methicillin-Resistant Staphylococcus aureus Among Household Members and the Home Environment Study."

Exclusion Criteria

* Households in which all members experienced SSTI during the 12-month observational study
* Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)

Eligible Sex

ALL

Accepts Healthy Volunteers

No