Trial Outcomes & Findings for Individualized vs. Household MRSA Decolonization (NCT NCT01814371)

NCT ID: NCT01814371

Last Updated: 2019-02-21

Results Overview

Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 474 participants
• Primary outcome timeframe: 3 months after enrollment
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	Individualized Approach The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Overall Study STARTED	248	226
Overall Study COMPLETED	218	199
Overall Study NOT COMPLETED	30	27

Reasons for withdrawal

Measure	Individualized Approach The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Overall Study Lost to Follow-up	30	27

Baseline Characteristics

Individualized vs. Household MRSA Decolonization

Baseline characteristics by cohort

Measure	Individualized Approach n=248 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=226 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Total n=474 Participants Total of all reporting groups
Age, Categorical <=18 years	145 Participants n=5 Participants	128 Participants n=7 Participants	273 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	97 Participants n=7 Participants	198 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	18.65 years STANDARD_DEVIATION 16.65 • n=5 Participants	18.69 years STANDARD_DEVIATION 15.94 • n=7 Participants	18.67 years STANDARD_DEVIATION 16.30 • n=5 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	124 Participants n=7 Participants	258 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	102 Participants n=7 Participants	216 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	232 Participants n=5 Participants	213 Participants n=7 Participants	445 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	67 Participants n=5 Participants	59 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) White	169 Participants n=5 Participants	162 Participants n=7 Participants	331 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	248 participants n=5 Participants	226 participants n=7 Participants	474 participants n=5 Participants
Height (inches)	54.95 inches STANDARD_DEVIATION 14.53 • n=5 Participants	55.24 inches STANDARD_DEVIATION 15.80 • n=7 Participants	55.09 inches STANDARD_DEVIATION 14.65 • n=5 Participants
Weight (pounds)	114.09 pounds STANDARD_DEVIATION 77.19 • n=5 Participants	121.74 pounds STANDARD_DEVIATION 88.25 • n=7 Participants	117.85 pounds STANDARD_DEVIATION 82.81 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months after enrollment

Population: 447 of 474 participants were analyzed. The remaining 27 participants were lost to follow up for this time frame.

Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol

Outcome measures

Measure	Individualized Approach n=235 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=212 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants With Incidence of SSTI at 3 Months After Decolonization	23 Participants	23 Participants

SECONDARY outcome

Timeframe: 1 month after enrollment

Population: 449 of 474 participants were analyzed. The remaining 25 participants were lost to follow up for this time frame.

Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol

Outcome measures

Measure	Individualized Approach n=237 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=212 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants With Incidence of SSTI at 1 Month After Decolonization	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: 434 of 474 participants were analyzed. The remaining 40 participants were lost to follow up for this time frame.

Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol

Outcome measures

Measure	Individualized Approach n=225 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=209 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants With Incidence of SSTI at 6 Months After Decolonization	32 Participants	33 Participants

SECONDARY outcome

Timeframe: 9 months after enrollment

Population: 433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame.

Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol

Outcome measures

Measure	Individualized Approach n=226 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=207 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants With Incidence of SSTI at 9 Months After Decolonization	39 Participants	35 Participants

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: 417 of 474 participants were analyzed. The remaining 57 participants were lost to follow up for this time frame.

Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol

Outcome measures

Measure	Individualized Approach n=218 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=199 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants With Incidence of SSTI at 12 Months After Decolonization	48 Participants	41 Participants

SECONDARY outcome

Timeframe: 1 month after enrollment

Population: 438 of 474 participants were analyzed. The remaining 36 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.

Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit

Outcome measures

Measure	Individualized Approach n=230 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=208 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Colonized With MRSA at 1 Month After Decolonization	45 Participants	20 Participants

SECONDARY outcome

Timeframe: 3 months after enrollment

Population: 433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.

Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit

Outcome measures

Measure	Individualized Approach n=224 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=209 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Colonized With MRSA at 3 Months After Decolonization	51 Participants	26 Participants

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: 431 of 474 participants were analyzed. The remaining 43 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.

Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit

Outcome measures

Measure	Individualized Approach n=227 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=204 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Colonized With MRSA at 6 Months After Decolonization	39 Participants	21 Participants

SECONDARY outcome

Timeframe: 9 months after enrollment

Population: 422 of 474 participants were analyzed. The remaining 52 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.

Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit

Outcome measures

Measure	Individualized Approach n=226 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=196 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Colonized With MRSA at 9 Months After Decolonization	40 Participants	17 Participants

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: 407 of 474 participants were analyzed. The remaining 67 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.

Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit

Outcome measures

Measure	Individualized Approach n=215 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=192 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Colonized With MRSA at 12 Months After Decolonization	47 Participants	22 Participants

SECONDARY outcome

Timeframe: 1 week after enrollment

Population: 309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. 4 participants did not complete any part of the assigned decolonization measures. The remaining 294 participants are analyzed.

Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.

Outcome measures

Measure	Individualized Approach n=84 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=210 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period	41 Participants	102 Participants

SECONDARY outcome

Timeframe: 1 month

Population: All participants swabbed before decolonization. 438 participants swabbed at 1 mo. follow-up (after decolonization) - remaining 36 lost to follow-up or unavailable for swabs at home visit. This SECONDARY outcome is independent of study group, as the impact of the study on mupirocin resistance in overall study population is the outcome measure.

Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol

Outcome measures

Measure	Individualized Approach n=808 Isolates Analyzed/Recovered The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=492 Isolates Analyzed/Recovered All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance	31 Isolates Analyzed/Recovered	20 Isolates Analyzed/Recovered

SECONDARY outcome

Timeframe: 1 month after enrollment

Population: 435 of 474 participants returned their cost of protocol documentation. This SECONDARY outcome is independent of study group, as the economic impact of the study in the overall study population is the outcome measure.

Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry

Outcome measures

Measure	Individualized Approach n=435 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Incurring Economic Burden of Performing Protocol	75 Participants	—

SECONDARY outcome

Timeframe: 1 Year

Population: 416 of 474 participants were analyzed. The remaining 58 participants were lost to follow up for this time frame and outcome.

Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.

Outcome measures

Measure	Individualized Approach n=218 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=198 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.	14 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 week

Population: 309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. The remaining 298 participants are analyzed.

Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)

Outcome measures

Measure	Individualized Approach n=86 Participants The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=212 Participants All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Number of Participants Adhering to Decolonization Measures	61 Participants	130 Participants

Adverse Events

Individualized Approach

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Household Approach

Serious events: 0 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Individualized Approach n=248 participants at risk The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.	Household Approach n=226 participants at risk All members of the household will perform the decolonization regimen. 2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. Hygiene Protocol: Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
General disorders Itching (from mupirocin)	2.4% 6/248 • 1 year	8.4% 19/226 • 1 year
General disorders Runny nose (from mupirocin)	4.4% 11/248 • 1 year	13.3% 30/226 • 1 year
General disorders Itching (from bleach baths)	4.4% 11/248 • 1 year	13.7% 31/226 • 1 year
General disorders Dry skin (from bleach baths)	9.7% 24/248 • 1 year	25.2% 57/226 • 1 year

Additional Information

Stephanie Fritz, MD, MSCI

Washington University School of Medicine

Phone: 3144544115

Email: fritz.s@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place