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: Active, not recruiting
• 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
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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
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
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
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 participants adhering to study intervention procedures	We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.	3 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 (Estimated): December 1, 2023
• Study Completion (Estimated): June 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): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Bacterial Infections; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Chlorhexidine; 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