Staph Household Intervention for Eradication (SHINE)

NCT ID: NCT02572791

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 835 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2024-12-31

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.

Conditions

Skin and Subcutaneous Tissue Bacterial Infections; Staphylococcus Aureus; MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

Mupirocin

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Household cleaning

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

Mupirocin

Intervention Type: DRUG

Household cleaning

Intervention Type: BEHAVIORAL

Interventions

Chlorhexidine

Intervention Type: DRUG

Mupirocin

Intervention Type: DRUG

Household cleaning

Intervention Type: BEHAVIORAL

Other Intervention Names

Hibiclens; Bactroban

Eligibility Criteria

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)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Stephanie A. Fritz

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie A Fritz, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

St. Louis Children's Hospital

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

3177 60559

Identifier Type: -

Identifier Source: org_study_id