Staph Household Intervention for Eradication (SHINE)

NCT02572791 | Completed Phase 4 Results DMC

• 1 other identifier: 3177 60559
• Study Type: interventional
• Target: 835
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Prevalence of MRSA Colonization in Participants

  Baseline sampling

• Prevalence of MRSA Colonization in Participants

  9 months

• Confirmed S. Aureus Infection

  9 months

• Incidence of SSTI

  1 month

• Incidence of SSTI

  6 months

Study Arms (3)

Periodic personal decolonization

EXPERIMENTAL

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; Drug: Mupirocin

Household environmental hygiene

EXPERIMENTAL

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

Integrated personal/household hygiene

EXPERIMENTAL

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; Drug: Mupirocin; Behavioral: Household cleaning

Interventions

Chlorhexidine DRUG

Also known as: Hibiclens

Integrated personal/household hygiene; Periodic personal decolonization

Mupirocin DRUG

Also known as: Bactroban

Integrated personal/household hygiene; Periodic personal decolonization

Household cleaning BEHAVIORAL

Household environmental hygiene; Integrated personal/household hygiene

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Chlorhexidine; chlorhexidine gluconate; Mupirocin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Limitations and Caveats

Due to the COVID-19 pandemic, we stopped early at 196, rather than 207 households.

Results Point of Contact

• Title: Dr. Stephanie Fritz
• Organization: Washington University School of Medicine

fritz.s@wustl.edu

3144546050

Study Officials

• Stephanie A Fritz, MD, MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (2)