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Completed

NCT Number: NCT01814371

Individualized vs. Household MRSA Decolonization

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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Key information

Conditions

Staphylococcal Skin Infection Abscess Animal Diseases Bacterial Infections Bacterial Infections and Mycoses Fish Diseases Furunculosis Gram-Positive Bacterial Infections Infections Inflammation MRSA Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Staphylococcus Aureus Suppuration

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

2% Mupirocin Ointment

Drug

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

Other names: Bactroban

Bleach Bath (dilute)

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.

Other names: Clorox

Hygiene protocol

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.

Primary outcomes

  1. Number of Participants With Incidence of SSTI at 3 Months After Decolonization

    Time frame: 3 months after enrollment

    Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol

Secondary outcomes

  1. Number of Participants With Incidence of SSTI at 1 Month After Decolonization

    Time frame: 1 month after enrollment

    Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol

  2. Number of Participants With Incidence of SSTI at 6 Months After Decolonization

    Time frame: 6 months after enrollment

    Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol

  3. Number of Participants With Incidence of SSTI at 9 Months After Decolonization

    Time frame: 9 months after enrollment

    Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol

  4. Number of Participants With Incidence of SSTI at 12 Months After Decolonization

    Time frame: 12 months after enrollment

    Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol

  5. Number of Participants Colonized With MRSA at 1 Month After Decolonization

    Time frame: 1 month after enrollment

    Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit

  6. Number of Participants Colonized With MRSA at 3 Months After Decolonization

    Time frame: 3 months after enrollment

    Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit

  7. Number of Participants Colonized With MRSA at 6 Months After Decolonization

    Time frame: 6 months after enrollment

    Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit

  8. Number of Participants Colonized With MRSA at 9 Months After Decolonization

    Time frame: 9 months after enrollment

    Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit

  9. Number of Participants Colonized With MRSA at 12 Months After Decolonization

    Time frame: 12 months after enrollment

    Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit

  10. Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period

    Time frame: 1 week after enrollment

    Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.

  11. Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance

    Time frame: 1 month

    Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol

  12. Number of Participants Incurring Economic Burden of Performing Protocol

    Time frame: 1 month after enrollment

    Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry

  13. Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.

    Time frame: 1 Year

    Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.

  14. Number of Participants Adhering to Decolonization Measures

    Time frame: 1 week

    Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Individualized vs. Household Eradication of MRSA in Households With Children

Acronym: HOME2DS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2013
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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