Staph Household Intervention for Eradication (SHINE)

Staphylococcus Aureus Clinical Trial

— SHINE  

Official title:

Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02572791
• Other study ID #: 3177 60559
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 835
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Skin and Subcutaneous Tissue Bacterial Infections
• Staphylococcal Infections
• Staphylococcus Aureus

Intervention

Drug:
• Chlorhexidine

• Mupirocin

Behavioral:
• Household cleaning

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SSTI	We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 3 months after randomization between the 3 intervention groups.	3 months after randomization
Secondary	Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces	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.	9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months).
Secondary	Incidence of SSTI	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 3 groups.	1 month, 6 months, and 9 months after randomization
Secondary	Confirmed S. aureus Infection	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.	9 months
Secondary	Number of patients with adverse events due to study intervention	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.	3 months
Secondary	Mupirocin resistance	Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.	9 months
Secondary	Number of participants adhering to study intervention procedures	We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.	3 months