Trial Outcomes & Findings for Staph Household Intervention for Eradication (SHINE) (NCT NCT02572791)
NCT ID: NCT02572791
Last Updated: 2026-02-24
Results Overview
Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
835 participants
Primary outcome timeframe
3 months after randomization
Results posted on
2026-02-24
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.
After the enrollment visit, all study participants (index patients and household contacts) were asked to perform a 5-day baseline decolonization regimen consisting of twice-daily application of 2% mupirocin ointment (Perrigo, Allegan, MI) to the anterior nares, and daily body washes with 4% chlorhexidine gluconate (Hibiclens, Mölnlycke Health Care, Norcross, GA).5,12,13,21,22 Participants \<2 months of age were excluded from performing the decolonization regimen.
Unit of analysis: Households
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Intervention Period: Months 0-3
STARTED
|
273 65
|
270 65
|
290 66
|
|
Intervention Period: Months 0-3
COMPLETED
|
228 57
|
235 58
|
255 59
|
|
Intervention Period: Months 0-3
NOT COMPLETED
|
45 8
|
35 7
|
35 7
|
|
Post-Intervention Period: Months 4-9
STARTED
|
229 57
|
235 58
|
256 59
|
|
Post-Intervention Period: Months 4-9
COMPLETED
|
213 53
|
222 56
|
242 55
|
|
Post-Intervention Period: Months 4-9
NOT COMPLETED
|
16 4
|
13 2
|
14 4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Intervention Period: Months 0-3
Lost to Follow-up
|
35
|
15
|
32
|
|
Intervention Period: Months 0-3
Withdrawal by Subject
|
8
|
8
|
1
|
|
Intervention Period: Months 0-3
Moved out of Household
|
2
|
12
|
2
|
|
Post-Intervention Period: Months 4-9
Lost to Follow-up
|
10
|
8
|
13
|
|
Post-Intervention Period: Months 4-9
Withdrawal by Subject
|
0
|
1
|
1
|
|
Post-Intervention Period: Months 4-9
Moved out of Household
|
6
|
4
|
0
|
Baseline Characteristics
Staph Household Intervention for Eradication (SHINE)
Baseline characteristics by cohort
| Measure |
Periodic Personal Decolonization
n=274 Participants
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.
|
Household Environmental Hygiene
n=270 Participants
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.
|
Integrated Personal/Household Hygiene
n=291 Participants
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.
|
Total
n=835 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15 Years
n=58 Participants
|
17 Years
|
13 Years
n=1 Participants
|
15 Years
n=484 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=58 Participants
|
145 Participants
|
165 Participants
n=1 Participants
|
469 Participants
n=484 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=58 Participants
|
125 Participants
|
126 Participants
n=1 Participants
|
366 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=58 Participants
|
6 Participants
|
5 Participants
n=1 Participants
|
17 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
268 Participants
n=58 Participants
|
264 Participants
|
286 Participants
n=1 Participants
|
818 Participants
n=484 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=58 Participants
|
5 Participants
|
7 Participants
n=1 Participants
|
17 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=58 Participants
|
83 Participants
|
95 Participants
n=1 Participants
|
234 Participants
n=484 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=58 Participants
|
163 Participants
|
175 Participants
n=1 Participants
|
533 Participants
n=484 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=58 Participants
|
19 Participants
|
14 Participants
n=1 Participants
|
51 Participants
n=484 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=484 Participants
|
|
Region of Enrollment
United States
|
274 participants
n=58 Participants
|
270 participants
|
291 participants
n=1 Participants
|
835 participants
n=484 Participants
|
|
Skin Infection in the Year Prior to Study Enrollment
|
85 number of participants w/skin infections
n=58 Participants
|
80 number of participants w/skin infections
|
64 number of participants w/skin infections
n=1 Participants
|
229 number of participants w/skin infections
n=484 Participants
|
PRIMARY outcome
Timeframe: 3 months after randomizationPopulation: We evaluated the primary outcome at the level of the household.
Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=60 Households
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.
|
Integrated Personal/Household Hygiene
n=60 Households
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.
|
Household Environmental Hygiene
n=60 Households
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.
|
|---|---|---|---|
|
Number of Households With at Least One Skin and Soft Tissue Infection
|
21 Households
|
21 Households
|
22 Households
|
SECONDARY outcome
Timeframe: Baseline samplingPopulation: Participants colonized with MRSA at the baseline sampling
Describe baseline prevalence of MRSA colonization in participants
Outcome measures
| Measure |
Periodic Personal Decolonization
n=274 Participants
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.
|
Integrated Personal/Household Hygiene
n=291 Participants
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.
|
Household Environmental Hygiene
n=270 Participants
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.
|
|---|---|---|---|
|
Prevalence of MRSA Colonization in Participants
|
39 Participants
|
61 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants cultured for MRSA detection at the 9 month study visit
Describe longitudinal MRSA colonization prevalence in participants
Outcome measures
| Measure |
Periodic Personal Decolonization
n=214 Participants
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.
|
Integrated Personal/Household Hygiene
n=244 Participants
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.
|
Household Environmental Hygiene
n=222 Participants
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.
|
|---|---|---|---|
|
Prevalence of MRSA Colonization in Participants
|
12 Participants
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants reporting SSTI throughout the longitudinal study
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=192 Participants
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.
|
Integrated Personal/Household Hygiene
n=144 Participants
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.
|
Household Environmental Hygiene
n=238 Participants
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.
|
|---|---|---|---|
|
Confirmed S. Aureus Infection
|
84 Participants
|
71 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Household level
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=61 Households
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.
|
Integrated Personal/Household Hygiene
n=60 Households
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.
|
Household Environmental Hygiene
n=61 Households
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.
|
|---|---|---|---|
|
Incidence of SSTI
|
14 Households
|
13 Households
|
16 Households
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Households
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=57 Households
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.
|
Integrated Personal/Household Hygiene
n=58 Households
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.
|
Household Environmental Hygiene
n=58 Households
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.
|
|---|---|---|---|
|
Incidence of SSTI
|
28 Households
|
27 Households
|
32 Households
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Households
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=56 Households
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.
|
Integrated Personal/Household Hygiene
n=58 Households
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.
|
Household Environmental Hygiene
n=58 Households
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.
|
|---|---|---|---|
|
Incidence of SSTI
|
30 Households
|
32 Households
|
38 Households
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Participants sampled at 9 months
Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=213 Participants
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.
|
Integrated Personal/Household Hygiene
n=242 Participants
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.
|
Household Environmental Hygiene
n=222 Participants
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.
|
|---|---|---|---|
|
Mupirocin Resistance
|
6 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants providing AE data
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=274 Participants
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.
|
Integrated Personal/Household Hygiene
n=269 Participants
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.
|
Household Environmental Hygiene
n=292 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Adverse Events Due to Study Intervention
|
111 Participants
|
92 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants completing the 3 month intervention
We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=247 Participants
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.
|
Integrated Personal/Household Hygiene
n=259 Participants
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.
|
Household Environmental Hygiene
n=246 Participants
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.
|
|---|---|---|---|
|
Number of Participants Adhering to Study Intervention Procedures
|
112 Participants
|
45 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: Individual Participants
Individual Participant SSTI Incidence
Outcome measures
| Measure |
Periodic Personal Decolonization
n=250 Participants
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.
|
Integrated Personal/Household Hygiene
n=262 Participants
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.
|
Household Environmental Hygiene
n=249 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Individual Level
|
18 Participants
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Participants
Individual Participant SSTI Incidence
Outcome measures
| Measure |
Periodic Personal Decolonization
n=235 Participants
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.
|
Integrated Personal/Household Hygiene
n=220 Participants
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.
|
Household Environmental Hygiene
n=225 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Individual Level
|
29 Participants
|
24 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Participants
Individual Participant SSTI Incidence
Outcome measures
| Measure |
Periodic Personal Decolonization
n=225 Participants
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.
|
Integrated Personal/Household Hygiene
n=248 Participants
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.
|
Household Environmental Hygiene
n=228 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Individual Level
|
39 Participants
|
31 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: Participants with SSTI in Prior Year
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=108 Participants
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.
|
Integrated Personal/Household Hygiene
n=101 Participants
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.
|
Household Environmental Hygiene
n=96 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
|
17 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Participants who Experienced an SSTI in the Year Prior to 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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=100 Participants
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.
|
Integrated Personal/Household Hygiene
n=96 Participants
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.
|
Household Environmental Hygiene
n=92 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
|
25 Participants
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Participants with SSTI in the Prior Year
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=97 Participants
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.
|
Integrated Personal/Household Hygiene
n=93 Participants
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.
|
Household Environmental Hygiene
n=90 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
|
32 Participants
|
33 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Participant with SSTI in the Prior Year
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.
Outcome measures
| Measure |
Periodic Personal Decolonization
n=95 Participants
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.
|
Integrated Personal/Household Hygiene
n=93 Participants
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.
|
Household Environmental Hygiene
n=89 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment
|
36 Participants
|
40 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 MonthPopulation: Index Patients
Cumulative Incidence of SSTI in Index Patients
Outcome measures
| Measure |
Periodic Personal Decolonization
n=61 Participants
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.
|
Integrated Personal/Household Hygiene
n=61 Participants
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.
|
Household Environmental Hygiene
n=60 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Index Patients
|
8 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Index Patients
Cumulative Incidence of SSTI in Index Patients
Outcome measures
| Measure |
Periodic Personal Decolonization
n=58 Participants
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.
|
Integrated Personal/Household Hygiene
n=60 Participants
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.
|
Household Environmental Hygiene
n=59 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Index Patients
|
15 Participants
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Index Patients
Cumulative Incidence of SSTI in Index Patients
Outcome measures
| Measure |
Periodic Personal Decolonization
n=57 Participants
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.
|
Integrated Personal/Household Hygiene
n=58 Participants
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.
|
Household Environmental Hygiene
n=57 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Index Patients
|
21 Participants
|
23 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 9 MonthsPopulation: Index Patients
Cumulative Incidence of SSTI in Index Patients
Outcome measures
| Measure |
Periodic Personal Decolonization
n=56 Participants
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.
|
Integrated Personal/Household Hygiene
n=58 Participants
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.
|
Household Environmental Hygiene
n=57 Participants
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.
|
|---|---|---|---|
|
SSTI Incidence: Index Patients
|
23 Participants
|
27 Participants
|
16 Participants
|
Adverse Events
Periodic Personal Decolonization
Serious events: 0 serious events
Other events: 111 other events
Deaths: 0 deaths
Household Environmental Hygiene
Serious events: 0 serious events
Other events: 93 other events
Deaths: 0 deaths
Integrated Personal/Household Hygiene
Serious events: 0 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Periodic Personal Decolonization
n=274 participants at risk
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.
Chlorhexidine
Mupirocin
|
Household Environmental Hygiene
n=269 participants at risk
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.
Household cleaning
|
Integrated Personal/Household Hygiene
n=292 participants at risk
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.
Chlorhexidine
Mupirocin
Household cleaning
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Adverse Event from Chlorhexidine application
|
22.3%
61/274 • Number of events 61 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
23.0%
62/269 • Number of events 62 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
34.6%
101/292 • Number of events 101 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
|
Skin and subcutaneous tissue disorders
Adverse Event from Mupirocin application
|
27.0%
74/274 • Number of events 74 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
23.8%
64/269 • Number of events 64 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
30.1%
88/292 • Number of events 88 • Adverse events were recorded during the baseline and 3 month intervention period (3.5 months).
|
Additional Information
Dr. Stephanie Fritz
Washington University School of Medicine
Phone: 3144546050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place