Individualized vs. Household MRSA Decolonization (HOME2DS)

Individualized vs. Household Eradication of MRSA in Households With Children

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcal Skin Infection; Abscess; Furunculosis; Staphylococcus Aureus; MRSA Infection
• Intervention / Treatment: Drug: 2% mupirocin ointment; Other: Bleach Bath (dilute); Behavioral: Hygiene Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 474
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Incidence of SSTI at 3 Months After Decolonization	Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol	3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Incidence of SSTI at 1 Month After Decolonization	Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol	1 month after enrollment
Number of Participants With Incidence of SSTI at 6 Months After Decolonization	Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol	6 months after enrollment
Number of Participants With Incidence of SSTI at 9 Months After Decolonization	Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol	9 months after enrollment
Number of Participants With Incidence of SSTI at 12 Months After Decolonization	Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol	12 months after enrollment
Number of Participants Colonized With MRSA at 1 Month After Decolonization	Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit	1 month after enrollment
Number of Participants Colonized With MRSA at 3 Months After Decolonization	Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit	3 months after enrollment
Number of Participants Colonized With MRSA at 6 Months After Decolonization	Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit	6 months after enrollment
Number of Participants Colonized With MRSA at 9 Months After Decolonization	Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit	9 months after enrollment
Number of Participants Colonized With MRSA at 12 Months After Decolonization	Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit	12 months after enrollment
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period	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.	1 week after enrollment
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance	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	1 month
Number of Participants Incurring Economic Burden of Performing Protocol	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	1 month after enrollment
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.	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.	1 Year
Number of Participants Adhering to Decolonization Measures	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)	1 week

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Stephanie A Fritz, MD, MSCI, Washington University School of Medicine

Publications and helpful links

General Publications

• Hogan PG, Parrish KL, Mork RL, Boyle MG, Muenks CE, Thompson RM, Morelli JJ, Sullivan ML, Hunstad DA, Bubeck Wardenburg J, Rzhetsky A, Gehlert SJ, Burnham CD, Fritz SA. HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4568-e4577. doi: 10.1093/cid/ciaa752.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 26, 2017
• Study Completion (Actual): November 28, 2017

Study Registration Dates

• First Submitted: March 15, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Abscesses; Furunculosis; Staphylococcus aureus colonization; Staphylococcal Skin Infection; MRSA
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Inflammation; Disease Attributes; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Suppuration; Skin Diseases, Bacterial; Infections; Communicable Diseases; Abscess; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Furunculosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin
• Other Study ID Numbers: R01HS021736 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No