Staph Household Intervention for Eradication (SHINE)
- Conditions
- Skin and Subcutaneous Tissue Bacterial InfectionsStaphylococcus AureusMRSA - Methicillin Resistant Staphylococcus Aureus Infection
- Interventions
- Registration Number
- NCT02572791
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 835
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Integrated personal/household hygiene Household cleaning Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2. Household environmental hygiene Household cleaning In addition to their usual cleaning, households will be asked to perform targeted household hygiene focusing on sources known to harbor S. aureus and serve as reservoirs for transmission. Integrated personal/household hygiene Chlorhexidine Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2. Periodic personal decolonization Chlorhexidine All household participants will perform chlorhexidine body washes twice weekly for 3 months and apply mupirocin ointment to the anterior nares twice daily for five consecutive days each month for 3 months. Periodic personal decolonization Mupirocin All household participants will perform chlorhexidine body washes twice weekly for 3 months and apply mupirocin ointment to the anterior nares twice daily for five consecutive days each month for 3 months. Integrated personal/household hygiene Mupirocin Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2.
- Primary Outcome Measures
Name Time Method Incidence of SSTI 3 months after randomization We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 3 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.
- Secondary Outcome Measures
Name Time Method Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces 9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months). Describe baseline and longitudinal prevalence of MRSA colonization in index patients, household contacts, pet dogs and cats, and household surfaces and compare between the 3 intervention groups.
Confirmed S. aureus Infection 9 months We will compare the development of a confirmed S. aureus infection between participants in the 3 groups over 9 months at the household and individual level.
Incidence of SSTI 1 month, 6 months, and 9 months after randomization We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 1 month, 6 months, and 9 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.
In addition to to the household level, we will also assess SSTI outcomes at the individual household member level, the index patient level, and the household contact level.Number of patients with adverse events due to study intervention 3 months We will describe the number of participants with adverse events due to study intervention (e.g., rhinorrhea, rash, dry skin) and compare between the three groups.
Mupirocin resistance 9 months Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.
Number of participants adhering to study intervention procedures 3 months We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.
Trial Locations
- Locations (2)
St. Louis Children's Hospital
🇺🇸St. Louis, Missouri, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States