Staph Household Intervention for Eradication (SHINE)
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/28/2019 |
| Start Date: | October 2015 |
| End Date: | December 2021 |
| Contact: | Stephanie A Fritz, MD, MSCI |
| Email: | fritz.s@wustl.edu |
| Phone: | 314 454 4115 |
Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection
The investigators propose a pragmatic comparative effectiveness trial evaluating several
decolonization strategies in patients with Staphylococcus aureus infection, their household
contacts, and household environmental surfaces. The central hypothesis of this proposal is
that an integrated approach of periodic personal and household environmental hygiene will
reduce S. aureus transmission in households and subsequently decrease the incidence of skin
and soft tissue infections (SSTI).
decolonization strategies in patients with Staphylococcus aureus infection, their household
contacts, and household environmental surfaces. The central hypothesis of this proposal is
that an integrated approach of periodic personal and household environmental hygiene will
reduce S. aureus transmission in households and subsequently decrease the incidence of skin
and soft tissue infections (SSTI).
Patients with active or recent S. aureus SSTI will be recruited from St. Louis Children's
Hospital and community pediatric practices affiliated with the investigators practice-based
research network. All participants (index patients and their household contacts) will perform
a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene
measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and
daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization
regimen, households will be randomized to one of three intervention groups: 1) Periodic
personal decolonization performed by all household members, to include chlorhexidine body
washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive
days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning
of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated
periodic personal decolonization and household environmental hygiene for 3 months. Households
will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the
prevalence of S. aureus colonization in the participants, household environmental surfaces,
and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain
typing will be performed on all recovered S. aureus isolates to illuminate transmission
dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the
investigators will assess resistance to the prescribed topical antimicrobials at baseline and
longitudinal samplings.
Hospital and community pediatric practices affiliated with the investigators practice-based
research network. All participants (index patients and their household contacts) will perform
a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene
measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and
daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization
regimen, households will be randomized to one of three intervention groups: 1) Periodic
personal decolonization performed by all household members, to include chlorhexidine body
washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive
days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning
of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated
periodic personal decolonization and household environmental hygiene for 3 months. Households
will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the
prevalence of S. aureus colonization in the participants, household environmental surfaces,
and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain
typing will be performed on all recovered S. aureus isolates to illuminate transmission
dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the
investigators will assess resistance to the prescribed topical antimicrobials at baseline and
longitudinal samplings.
Inclusion Criteria:
- Patients 18 years of age and younger
- Confirmed (i.e., culture-positive) active or recent (within the past 2 months) S.
aureus cutaneous infections
- Reside within 75 miles of St. Louis Children's Hospital
- Provide written, informed consent, or consent is provided by a parent or legal
guardian
Exclusion Criteria:
- Patients with nosocomial infections (i.e., >48 hours after hospitalization)
- Patients with traditional risk factors for HA-MRSA (e.g., immunodeficiency, indwelling
catheter or percutaneous medical device, undergoing dialysis, presenting with a
surgical site infection, or residing in a long-term care facility within the past
year).
- Patients who are unable to give consent or for whom consent is not obtained
- Patients refusing home environmental cultures by the study team
- Patients without a permanent home (e.g., living in a shelter or group home)
We found this trial at
2
sites
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Stephanie A Fritz, MD, MSCI
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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