Staph Household Intervention for Eradication (SHINE) (SHINE)

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).

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Skin and Subcutaneous Tissue Bacterial Infections; MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Intervention / Treatment: Drug: Chlorhexidine; Drug: Mupirocin; Behavioral: Household cleaning

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.

• Study Type: Interventional
• Enrollment (Actual): 835
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periodic personal decolonization; 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.	Drug: Chlorhexidine; Other Names: Hibiclens; Drug: Mupirocin; Other Names: Bactroban
Experimental: Household environmental hygiene; 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.	Behavioral: Household cleaning
Experimental: Integrated personal/household hygiene; 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.	Drug: Chlorhexidine; Other Names: Hibiclens; Drug: Mupirocin; Other Names: Bactroban; Behavioral: Household cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Households With at Least One Skin and Soft Tissue Infection	Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.	3 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of MRSA Colonization in Participants	Describe baseline prevalence of MRSA colonization in participants	Baseline sampling
Prevalence of MRSA Colonization in Participants	Describe longitudinal MRSA colonization prevalence in participants	9 months
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
Incidence of SSTI	We will compare the number of households in which at least one household member develops SSTI 1 month after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.	1 month
Incidence of SSTI	We will compare the incidence of households in which at least one household member experiences an SSTI at the household level 6 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.	6 months
Incidence of SSTI	We will compare the number of households in which at least one household member develops SSTI 9 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.	9 months
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
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
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
SSTI Incidence: Individual Level	Individual Participant SSTI Incidence	1 Month
SSTI Incidence: Individual Level	Individual Participant SSTI Incidence	3 Months
SSTI Incidence: Individual Level	Individual Participant SSTI Incidence	6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	Incidence of SSTI in Participants who Experienced an SSTI in the Year Prior to Enrollment. During the enrollment survey, all participants were asked if they had ever had an SSTI, and when the SSTI occurred. If a participant had experienced an SSTI before joining this study, and that SSTI occurred less than a year before their enrollment date, they were included in this subgroup.	1 Month
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	Incidence of SSTI in Participants who Experienced an SSTI in the Year Prior to Enrollment. During the enrollment survey, all participants were asked if they had ever had an SSTI, and when the SSTI occurred. If a participant had experienced an SSTI before joining this study, and that SSTI occurred less than a year before their enrollment date, they were included in this subgroup.	3 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	Incidence of SSTI in Participants who Experienced an SSTI in the Year Prior to Enrollment. During the enrollment survey, all participants were asked if they had ever had an SSTI, and when the SSTI occurred. If a participant had experienced an SSTI before joining this study, and that SSTI occurred less than a year before their enrollment date, they were included in this subgroup.	6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	Incidence of SSTI in Participants who Experienced an SSTI in the Year Prior to Enrollment. During the enrollment survey, all participants were asked if they had ever had an SSTI, and when the SSTI occurred. If a participant had experienced an SSTI before joining this study, and that SSTI occurred less than a year before their enrollment date, they were included in this subgroup.	9 Months
SSTI Incidence: Index Patients	Cumulative Incidence of SSTI in Index Patients	1 Month
SSTI Incidence: Index Patients	Cumulative Incidence of SSTI in Index Patients	3 Months
SSTI Incidence: Index Patients	Cumulative Incidence of SSTI in Index Patients	6 Months
SSTI Incidence: Index Patients	Cumulative Incidence of SSTI in Index Patients	9 Months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Stephanie A Fritz, MD, MSCI, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimated): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Staphylococcal Infections; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines; Chlorhexidine; Mupirocin; chlorhexidine gluconate
• Other Study ID Numbers: 3177 60559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No