Household Observation of MRSA in the Environment 2: Decolonization Protocol (HOME 2)

Staphylococcus aureus (also referred to as “Staph”) is a germ that commonly lives on the skin or in the nose of healthy people (this is known as colonization). This Staph germ may cause skin infections and rarely can cause more serious infections such as pneumonia or bone or joint infections. Some physicians recommend hygiene measures and topical antibiotics or antiseptics to eliminate Staph from the skin and nose (these measures are referred to as “decolonization”) in an effort to prevent the Staph germ from returning and causing infection.

We know that multiple household members may be affected by the Staph germ (by colonization and/or infection). However, it is unclear which household members should perform decolonization. The goal of the HOME 2 study (Household Observation of MRSA in the Environment: Decolonization Protocol) is to compare the effectiveness of commonly used decolonization treatments when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year in comparison to decolonization of all household members in preventing Staph infections from returning. The decolonization treatments consist of hygiene measures, applying antibiotic ointment (mupirocin) to the inside tip of the nose and bathing in dilute bleach water (about the same concentration as a swimming pool). If you and your household members decide to participate in the HOME 2 study, the study team will come to your home 5 times over 1 year.

Who is eligible to participate in the HOME 2 study?

• Patients aged 6 months to 21 years who have completed the HOME study.
• There are no restrictions for household contacts.

Who is not eligible?

• Patients without a permanent home (e.g., living in a shelter or group home)
• Patients on dialysis and those with a central catheter or immunodeficiency
• Patients residing in a long-term care facility within the past year
• Individuals unable to give consent or who do not speak English
• Families refusing home environment cultures by the study team

What is involved in participation?

• The study team will come to your home 6 times over the course of a year, with follow up visits at 1, 3, 6, 9, and 12 months.
• Each participating household member will receive monetary compensation for their time as follows (totaling $135 for all 5 visits over the 12 month study):
  • Enrollment $20
  • Visit 1 $20
  • Visit 2 $20
  • Visit 3 $20
  • Visit 4 $25
  • Visit 5 $30

At the enrollment visit

• The study team will come to your home and explain the research study to all interested members of your household. Each household member who wishes to participate in the study will sign a consent document agreeing to partake in the study.
• Each household member will answer questions about his or her health, hygiene habits, and activities and have culture swabs taken from the nostrils, underarms, and underwear line (or where the leg meets the body).
• The study team will ask questions about your house and will collect samples from frequently touched household surfaces.
• Samples will be collected from the nose and fur of indoor pet dogs and cats.
• Households will be randomized to one of two groups:
• Household Group: All members of the household will apply 2% mupirocin ointment to the inside tip of the nose two times a day for 5 days and will bathe (15-minute soaks) in dilute bleach water every day for 5 days.
• Affected Group: Only household members with a skin or soft tissue infection in the past year will perform the decolonization measures described above.
• All participants will receive hygiene education and all materials to perform decolonization measures.

At each follow-up visit

• Each household member will answer questions about his or her health, hygiene habits, and activities and have culture swabs taken from the nostrils, underarms, and underwear line (or where the leg meets the body).
• The study team will ask questions about your house and will collect samples from frequently touched household surfaces.
• Samples will be collected from the nose and fur of indoor pet dogs and cats.

The information we learn from this study will help us design better treatments to stop the spread of the Staph germ and prevent infections.