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Completed

NCT Number: NCT02572791

Staph Household Intervention for Eradication (SHINE)

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).

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Key information

Conditions

Skin and Subcutaneous Tissue Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections MRSA - Methicillin Resistant Staphylococcus Aureus Infection Staphylococcal Infections Staphylococcus Aureus

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Louis Children's Hospital, St Louis, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chlorhexidine

Drug

Other names: Hibiclens

Mupirocin

Drug

Other names: Bactroban

Household cleaning

Behavioral

Primary outcomes

  1. Number of Households With at Least One Skin and Soft Tissue Infection

    Time frame: 3 months after randomization

    Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.

Secondary outcomes

  1. Prevalence of MRSA Colonization in Participants

    Time frame: Baseline sampling

    Describe baseline prevalence of MRSA colonization in participants

  2. Prevalence of MRSA Colonization in Participants

    Time frame: 9 months

    Describe longitudinal MRSA colonization prevalence in participants

  3. Confirmed S. Aureus Infection

    Time frame: 9 months

    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.

  4. Incidence of SSTI

    Time frame: 1 month

    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.

  5. Incidence of SSTI

    Time frame: 6 months

    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. Incidence of SSTI

    Time frame: 9 months

    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.

  7. Mupirocin Resistance

    Time frame: 9 months

    Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.

  8. Number of Patients With Adverse Events Due to Study Intervention

    Time frame: 3 months

    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.

  9. Number of Participants Adhering to Study Intervention Procedures

    Time frame: 3 months

    We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.

  10. SSTI Incidence: Individual Level

    Time frame: 1 Month

    Individual Participant SSTI Incidence

  11. SSTI Incidence: Individual Level

    Time frame: 3 Months

    Individual Participant SSTI Incidence

  12. SSTI Incidence: Individual Level

    Time frame: 6 Months

    Individual Participant SSTI Incidence

  13. SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment

    Time frame: 1 Month

    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.

  14. SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment

    Time frame: 3 Months

    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.

  15. SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment

    Time frame: 6 Months

    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.

  16. SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment

    Time frame: 9 Months

    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.

  17. SSTI Incidence: Index Patients

    Time frame: 1 Month

    Cumulative Incidence of SSTI in Index Patients

  18. SSTI Incidence: Index Patients

    Time frame: 3 Months

    Cumulative Incidence of SSTI in Index Patients

  19. SSTI Incidence: Index Patients

    Time frame: 6 Months

    Cumulative Incidence of SSTI in Index Patients

  20. SSTI Incidence: Index Patients

    Time frame: 9 Months

    Cumulative Incidence of SSTI in Index Patients

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: SHINE

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2015
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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