CompletedNCT02572791SHINEUpdated Feb 24, 2026Results posted

Staph Household Intervention for Eradication (SHINE)

A Phase 4 interventional study of Chlorhexidine and Mupirocin in Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus and MRSA - Methicillin Resistant Staphylococcus Aureus Infection, sponsored by Washington University School of Medicine. Completed at 2 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 835
Allocation: Randomized
Ages: Up to 18 Years
Sex: All

Study 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).

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 studied

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

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Staphylococcal Infections 273

In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 835 is above the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 835 participants (actual)

Study arms

Experimental
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.
Drug: Chlorhexidine · Drug: Mupirocin
Experimental
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.
Behavioral: Household cleaning
Experimental
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.
Drug: Chlorhexidine · Drug: Mupirocin · Behavioral: Household cleaning

Interventions

DrugChlorhexidine
Also known as: Hibiclens
DrugMupirocin
Also known as: Bactroban
BehavioralHousehold cleaning

What researchers measure

Primary outcomes

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.
Time frame: 3 months after randomization

Secondary outcomes

Prevalence of MRSA Colonization in Participants
Describe baseline prevalence of MRSA colonization in participants
Time frame: Baseline sampling
Prevalence of MRSA Colonization in Participants
Describe longitudinal MRSA colonization prevalence in participants
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Time frame: 1 Month
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Time frame: 3 Months
SSTI Incidence: Individual Level
Individual Participant SSTI Incidence
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Time frame: 1 Month
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Time frame: 3 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Time frame: 6 Months
SSTI Incidence: Index Patients
Cumulative Incidence of SSTI in Index Patients
Time frame: 9 Months

Results

Posted Feb 24, 2026

Limitations and caveats

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

Participant flow

From 2015-2021, pediatric patients with culture-confirmed, community-onset S. aureus SSTIs ("index patients") were recruited from St. Louis Children's Hospital (SLCH) and community pediatric practices in metropolitan St. Louis. Children with nosocomial infections, healthcare-related risk factors, or immunodeficiency were excluded. Household contacts (individuals sleeping in the home ≥4 nights per week) were also enrolled. All study visits were conducted in participants' homes.

Intervention Period: Months 0-3

Participant flow — Intervention Period: Months 0-3
Milestone	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
Started	273	270	290
Completed	228	235	255
Not completed	45	35	35
Withdrew: Lost to follow-up	35	15	32
Withdrew: Withdrawal by subject	8	8	1
Withdrew: Moved out of household	2	12	2

Post-Intervention Period: Months 4-9

Participant flow — Post-Intervention Period: Months 4-9
Milestone	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
Started	229	235	256
Completed	213	222	242
Not completed	16	13	14
Withdrew: Lost to follow-up	10	8	13
Withdrew: Withdrawal by subject	0	1	1
Withdrew: Moved out of household	6	4	0

Outcome measures

PrimaryNumber 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.

Time frame:: 3 months after randomization
Reported as:: Count of units · Households

Number of Households With at Least One Skin and Soft Tissue Infection
Households	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Number of Households With at Least One Skin and Soft Tissue Infection	21	21	22

SecondaryPrevalence of MRSA Colonization in Participants

Describe baseline prevalence of MRSA colonization in participants

Time frame:: Baseline sampling
Reported as:: Count of participants · Participants

Prevalence of MRSA Colonization in Participants
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Prevalence of MRSA Colonization in Participants	39	61	60

SecondaryPrevalence of MRSA Colonization in Participants

Describe longitudinal MRSA colonization prevalence in participants

Time frame:: 9 months
Reported as:: Count of participants · Participants

Prevalence of MRSA Colonization in Participants
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Prevalence of MRSA Colonization in Participants	12	22	24

SecondaryConfirmed 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.

Time frame:: 9 months
Reported as:: Count of participants · Participants

Confirmed S. Aureus Infection
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Confirmed S. Aureus Infection	84	71	135

SecondaryIncidence 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.

Time frame:: 1 month
Reported as:: Count of units · Households

Incidence of SSTI
Households	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Incidence of SSTI	14	13	16

SecondaryIncidence 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.

Time frame:: 6 months
Reported as:: Count of units · Households

Incidence of SSTI
Households	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Incidence of SSTI	28	27	32

SecondaryIncidence 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.

Time frame:: 9 months
Reported as:: Count of units · Households

Incidence of SSTI
Households	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Incidence of SSTI	30	32	38

SecondaryMupirocin Resistance

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
Reported as:: Count of participants · Participants

Mupirocin Resistance
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Mupirocin Resistance	6	1	2

SecondaryNumber 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.

Time frame:: 3 months
Reported as:: Count of participants · Participants

Number of Patients With Adverse Events Due to Study Intervention
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
Number of Patients With Adverse Events Due to Study Intervention	111	92	137

SecondaryNumber of Participants Adhering to Study Intervention Procedures

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

Time frame:: 3 months
Reported as:: Count of participants · Participants

Number of Participants Adhering to Study Intervention Procedures
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
Number of Participants Adhering to Study Intervention Procedures	112	45	55

SecondarySSTI Incidence: Individual Level

Individual Participant SSTI Incidence

Time frame:: 1 Month
Reported as:: Count of participants · Participants

SSTI Incidence: Individual Level
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
SSTI Incidence: Individual Level	18	16	19

SecondarySSTI Incidence: Individual Level

Individual Participant SSTI Incidence

Time frame:: 3 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Individual Level
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
SSTI Incidence: Individual Level	29	24	29

SecondarySSTI Incidence: Individual Level

Individual Participant SSTI Incidence

Time frame:: 6 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Individual Level
Participants	Periodic Personal Decolonization	Integrated Personal/Household Hygiene	Household Environmental Hygiene
SSTI Incidence: Individual Level	39	31	43

SecondarySSTI 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.

Time frame:: 1 Month
Reported as:: Count of participants · Participants

SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	17	13	10

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

Time frame:: 3 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	25	22	18

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

Time frame:: 6 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	32	33	20

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

Time frame:: 9 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	36	40	25

SecondarySSTI Incidence: Index Patients

Cumulative Incidence of SSTI in Index Patients

Time frame:: 1 Month
Reported as:: Count of participants · Participants

SSTI Incidence: Index Patients
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Index Patients	8	11	7

SecondarySSTI Incidence: Index Patients

Cumulative Incidence of SSTI in Index Patients

Time frame:: 3 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Index Patients
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Index Patients	15	16	12

SecondarySSTI Incidence: Index Patients

Cumulative Incidence of SSTI in Index Patients

Time frame:: 6 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Index Patients
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Index Patients	21	23	13

SecondarySSTI Incidence: Index Patients

Cumulative Incidence of SSTI in Index Patients

Time frame:: 9 Months
Reported as:: Count of participants · Participants

SSTI Incidence: Index Patients
Participants	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
SSTI Incidence: Index Patients	23	27	16

Adverse events

Collected over Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Periodic Personal Decolonization	0/274 (0%)	0/274 (0%)	111/274 (40.5%)
Household Environmental Hygiene	0/269 (0%)	0/269 (0%)	93/269 (34.6%)
Integrated Personal/Household Hygiene	0/292 (0%)	0/292 (0%)	137/292 (46.9%)

Most frequent other events

Most frequent other events
Event	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene
Adverse Event from Chlorhexidine applicationSkin and subcutaneous tissue disorders	61/274	62/269	101/292
Adverse Event from Mupirocin applicationSkin and subcutaneous tissue disorders	74/274	64/269	88/292

Baseline characteristics

819 participants from 196 households were enrolled at the baseline study visit. And additional 16 participants subsequently joined the households during the 9-month longitudinal study and were enrolled; their information is captured in the demographic information provided.

Age, Continuous
Age, Continuous(Years)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
Median	15 (0.04 to 59)	17 (0.01 to 61)	13 (0.02 to 75)	15 (0.01 to 75)

Sex: Female, Male
Sex: Female, Male(Participants)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
Female	159	145	165	469
Male	115	125	126	366

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
Hispanic or Latino	6	6	5	17
Not Hispanic or Latino	268	264	286	818
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
American Indian or Alaska Native	0	0	0	0
Asian	5	5	7	17
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	56	83	95	234
White	195	163	175	533
More than one race	18	19	14	51
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
United States	274	270	291	835

Skin Infection in the Year Prior to Study Enrollment
Skin Infection in the Year Prior to Study Enrollment(number of participants w/skin infections)	Periodic Personal Decolonization	Household Environmental Hygiene	Integrated Personal/Household Hygiene	Total
Number	85	80	64	229

Study locations

2 sites

St. Louis Children's Hospital
St Louis, Missouri 63110, United States
Washington University School of Medicine
St Louis, Missouri 63110, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 10, 2025

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02572791
Lead sponsor: Washington University School of Medicine
Responsible party: Stephanie A. Fritz (Professor of Pediatrics, Washington University School of Medicine) — Principal investigator
First posted: Oct 9, 2015
Start date: Oct 2015
Primary completion: Nov 2024
Completion: Dec 2024
Results posted: Feb 24, 2026
Last update: Feb 24, 2026

Study contacts

Stephanie A Fritz, MD, MSCI

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Staph Household Intervention for Eradication (SHINE)

Study summary

Conditions studied

Browse trials for

In context

Staphylococcal Infections

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria