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Staph Household Intervention for Eradication (SHINE) (SHINE)

Primary Purpose

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

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Mupirocin
Household cleaning
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Subcutaneous Tissue Bacterial Infections

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • St. Louis Children's Hospital
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Periodic personal decolonization

Household environmental hygiene

Integrated personal/household hygiene

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2015
Last Updated
July 27, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02572791
Brief Title
Staph Household Intervention for Eradication (SHINE)
Acronym
SHINE
Official Title
Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus, MRSA - Methicillin Resistant Staphylococcus Aureus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
835 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodic personal decolonization
Arm Type
Experimental
Arm Description
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.
Arm Title
Household environmental hygiene
Arm Type
Experimental
Arm Description
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.
Arm Title
Integrated personal/household hygiene
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
Hibiclens
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
Bactroban
Intervention Type
Behavioral
Intervention Name(s)
Household cleaning
Primary Outcome Measure Information:
Title
Incidence of SSTI
Description
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.
Time Frame
3 months after randomization
Secondary Outcome Measure Information:
Title
Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces
Description
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.
Time Frame
9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months).
Title
Incidence of SSTI
Description
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.
Time Frame
1 month, 6 months, and 9 months after randomization
Title
Confirmed S. aureus Infection
Description
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.
Time Frame
9 months
Title
Number of patients with adverse events due to study intervention
Description
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.
Time Frame
3 months
Title
Mupirocin resistance
Description
Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.
Time Frame
9 months
Title
Number of participants adhering to study intervention procedures
Description
We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Fritz, MD, MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Staph Household Intervention for Eradication (SHINE)

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