Clinical Trial: Individualized vs. Household MRSA Decolonization

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Individualized vs. Household Eradication of MRSA in Households With Children

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.

Detailed Summary:

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.


Sponsor: Washington University School of Medicine

Current Primary Outcome: Incidence of SSTI in study participants 3 months after decolonization [ Time Frame: 3 months after enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SSTI incidence 1 month after performing decolonization measures [ Time Frame: 1 month after enrollment ]
  • SSTI incidence 6 months after performing decolonization measures [ Time Frame: 6 months after enrollment ]
  • SSTI incidence 9 months after performing decolonization measures [ Time Frame: 9 months after enrollment ]
  • SSTI incidence 12 months after performing decolonization measures [ Time Frame: 12 months after enrollment ]
  • Colonization status at the 1 month study visit [ Time Frame: 1 month after enrollment ]
  • Colonization status at the 3 month study visit [ Time Frame: 3 months after enrollment ]
  • Colonization status at the 6 month study visit [ Time Frame: 6 months after enrollment ]
  • Colonization status at the 9 month study visit [ Time Frame: 9 months after enrollment ]
  • Colonization status at the 12 month study visit [ Time Frame: 12 months after enrollment ]
  • Development of adverse effects occurring during the 5-day decolonization period [ Time Frame: 1 week after enrollment ]
    Nasal burning, itching, stinging, or runny nose. Dry skin, itching, or rash.
  • Detection of high-level mupirocin resistance in recovered MRSA strains [ Time Frame: 1 year ]
  • Economic burden of performing decolonization [ Time Frame: 1 month after enrollment ]
    Cost 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
  • Development of a confirmed MRSA infection over the 12-month longitudinal study period. [ Time Frame: 1 Year ]
  • Adherence to decolonization measures [ Time Frame: 1 month ]


Original Secondary Outcome:

  • SSTI incidence 1 month after performing decolonization measures [ Time Frame: 1 month after enrollment ]
  • SSTI incidence 6 months after performing decolonization measures [ Time Frame: 6 months after enrollment ]
  • SSTI incidence 9 months after performing decolonization measures [ Time Frame: 9 months after enrollment ]
  • SSTI incidence 12 months after performing decolonization measures [ Time Frame: 12 months after enrollment ]
  • Colonization status at the 1 month study visit [ Time Frame: 1 month after enrollment ]
  • Colonization status at the 3 month study visit [ Time Frame: 3 months after enrollment ]
  • Colonization status at the 6 month study visit [ Time Frame: 6 months after enrollment ]
  • Colonization status at the 9 month study visit [ Time Frame: 9 months after enrollment ]
  • Colonization status at the 12 month study visit [ Time Frame: 12 months after enrollment ]
  • Number of participants with adverse effects occurring during the 5-day decolonization period [ Time Frame: 1 week after enrollment ]
  • Detection of high-level mupirocin resistance in recovered MRSA strains [ Time Frame: 1 year ]
  • Economic burden of performing decolonization [ Time Frame: 1 month after enrollment ]
  • Development of a confirmed MRSA infection over the 12-month longitudinal study period. [ Time Frame: 1 Year ]
  • Adherence to decolonization measures [ Time Frame: 1 month ]


Information By: Washington University School of Medicine

Dates:
Date Received: March 15, 2013
Date Started: April 2013
Date Completion: December 31, 2017
Last Updated: May 11, 2017
Last Verified: May 2017