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Trial record 11 of 17 for:    "Connective Tissue Disease" | "Ethanol"

Individualized vs. Household MRSA Decolonization (HOME2DS)

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ClinicalTrials.gov Identifier: NCT01814371
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : October 26, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Staphylococcal Skin Infection Abscess Furunculosis Staphylococcus Aureus MRSA Infection Drug: 2% mupirocin ointment Other: Bleach Bath (dilute) Behavioral: Hygiene Protocol Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Individualized vs. Household Eradication of MRSA in Households With Children
Study Start Date : April 2013
Actual Primary Completion Date : February 26, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Individualized Approach
The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Drug: 2% mupirocin ointment
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
Other Name: Bactroban

Other: 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.
Other Name: Clorox

Behavioral: 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.

Active Comparator: Household Approach
All members of the household will perform the decolonization regimen.
Drug: 2% mupirocin ointment
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
Other Name: Bactroban

Other: 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.
Other Name: Clorox

Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814371


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Stephanie A Fritz, MD, MSCI Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Stephanie A. Fritz, Washington University School of Medicine:

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Responsible Party: Stephanie A. Fritz, Assistant Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01814371     History of Changes
Other Study ID Numbers: R01HS021736 ( U.S. AHRQ Grant/Contract )
First Posted: March 19, 2013    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: February 21, 2019
Last Verified: February 2019

Keywords provided by Stephanie A. Fritz, Washington University School of Medicine:
Abscesses
Furunculosis
Staphylococcus aureus colonization
Staphylococcal Skin Infection
MRSA

Additional relevant MeSH terms:
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Connective Tissue Diseases
Infection
Communicable Diseases
Abscess
Cellulitis
Skin Diseases, Infectious
Staphylococcal Skin Infections
Furunculosis
Suppuration
Inflammation
Pathologic Processes
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action