Skin and Subcutaneous Tissue Bacterial InfectionsPhase 4SHINENCT02572791
Staph Household Intervention for Eradication (SHINE)
A Phase 4 study testing Chlorhexidine, Mupirocin and Household cleaning in people with Skin and Subcutaneous Tissue Bacterial Infections and Staphylococcus Aureus, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus, MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- What is being tested?
- Chlorhexidine, Mupirocin and Household cleaning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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).
Read the 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
- Being tested
- Chlorhexidine, Mupirocin, Household cleaning
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called Hibiclens
MupirocinDrug
Also called Bactroban
Household cleaningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Chlorhexidine; Drug: Mupirocin; Behavioral: Household cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after randomization
Secondary outcomes (20)
Prevalence of MRSA Colonization in Participants
Describe baseline prevalence of MRSA colonization in participants
Measured: Baseline sampling
Prevalence of MRSA Colonization in Participants
Describe longitudinal MRSA colonization prevalence in participants
Measured: 9 months
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.
Measured: 9 months
Incidence of SSTI
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.
Measured: 1 month
Incidence of SSTI
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.
Measured: 6 months
Incidence of SSTI
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.
Measured: 9 months
Mupirocin Resistance
Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.
Measured: 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.
Measured: 3 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.
Measured: 3 months
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Measured: 1 Month
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Measured: 3 Months
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Measured: 6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
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.
Measured: 1 Month
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
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.
Measured: 3 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
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.
Measured: 6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
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.
Measured: 9 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Measured: 1 Month
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Measured: 3 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Measured: 6 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin and Subcutaneous Tissue Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie A. Fritz, Washington University School of Medicine
- Investigators
- Stephanie A Fritz, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572791
- Sponsor's protocol ID
- 3177 60559
- Acronym
- SHINE
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2015
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection
- ClinicalTrials.gov ID
- NCT02572791
- Acronym / sponsor ID
- SHINE / 3177 60559
- Conditions
- Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus, MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodic personal decolonization | Experimental | Drug: Chlorhexidine, Drug: MupirocinAll 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. |
| Household environmental hygiene | Experimental | Behavioral: Household cleaningIn 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. |
| Integrated personal/household hygiene | Experimental | Drug: Chlorhexidine, Drug: Mupirocin, Behavioral: Household cleaningParticipants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineAlso: Hibiclens | Drug | Integrated personal/household hygiene, Periodic personal decolonization |
| MupirocinAlso: Bactroban | Drug | Integrated personal/household hygiene, Periodic personal decolonization |
| Household cleaning | Behavioural | Household environmental hygiene, Integrated personal/household hygiene |
Primary outcome
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.
20 secondary outcomes
Prevalence of MRSA Colonization in Participants
Time frame: Baseline sampling
Prevalence of MRSA Colonization in Participants
Time frame: 9 months
Confirmed S. Aureus Infection
Time frame: 9 months
Incidence of SSTI
Time frame: 1 month
Incidence of SSTI
Time frame: 6 months
Incidence of SSTI
Time frame: 9 months
Mupirocin Resistance
Time frame: 9 months
Number of Patients With Adverse Events Due to Study Intervention
Time frame: 3 months
Number of Participants Adhering to Study Intervention Procedures
Time frame: 3 months
SSTI Incidence: Individual Level
Time frame: 1 Month
SSTI Incidence: Individual Level
Time frame: 3 Months
SSTI Incidence: Individual Level
Time frame: 6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Time frame: 1 Month
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Time frame: 3 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Time frame: 6 Months
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Time frame: 9 Months
SSTI Incidence: Index Patients
Time frame: 1 Month
SSTI Incidence: Index Patients
Time frame: 3 Months
SSTI Incidence: Index Patients
Time frame: 6 Months
SSTI Incidence: Index Patients
Time frame: 9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Fritz, MD, MSCI principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine, Mupirocin and Household cleaning in people with Skin and Subcutaneous Tissue Bacterial Infections and Staphylococcus Aureus, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Households With at Least One Skin and Soft Tissue Infection (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.