Trial Outcomes & Findings for MRSA Eradication and Decolonization in Children (NCT NCT02127658)
NCT ID: NCT02127658
Last Updated: 2024-06-25
Results Overview
Recurrence of skin and soft tissue infections at follow up periods (6 weeks, 6 months, and 12 months). At least 1 follow up must be completed.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
12 months
Results posted on
2024-06-25
Participant Flow
In-person recruitment will be done in the pediatric surgery outpatient clinic located in the Riley Outpatient Center Riley Hospital for Children, Indiana University Health, Indianapolis, Indiana. Recruitment will also be done via phone for patients who had an incision and draining procedure of a culture-confirmed Methicillin-Resistant Staphylococcus Aureus (MRSA) abscess in the Riley Emergency Department (ED), Riley Operating Room (OR), or IU Health North Operating Room (OR).
Participant milestones
| Measure |
Hygiene Education
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
6 Week Follow-up
|
5
|
4
|
|
Overall Study
6 Month Follow-up
|
5
|
3
|
|
Overall Study
12 Month Follow-up
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Hygiene Education
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Overall Study
Screen Fail (Not MRSA on culture check)
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
MRSA Eradication and Decolonization in Children
Baseline characteristics by cohort
| Measure |
Hygiene Education
n=7 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=7 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.6 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
3.5 years
STANDARD_DEVIATION 4.67 • n=7 Participants
|
3.5 years
STANDARD_DEVIATION 3.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Surgical Drainage procedure location
Operating Room
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Surgical Drainage procedure location
Emergency Department
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants with at least 1 study evaluation at 6 weeks, 6 months, or 12 months.
Recurrence of skin and soft tissue infections at follow up periods (6 weeks, 6 months, and 12 months). At least 1 follow up must be completed.
Outcome measures
| Measure |
Hygiene Education
n=5 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsInterval repeat surgery or Incision/Drainage procedure for skin and soft tissue infection assessed at follow up periods (6 weeks, 6 months, and 12 months). At least 1 follow up must be completed.
Outcome measures
| Measure |
Hygiene Education
n=5 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsParents of participants will be asked whether their child have missed any school days due to MRSA SSTI. Parents will be asked about number of school days missed.
Outcome measures
| Measure |
Hygiene Education
n=5 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Participants Who Missed School Due to MRSA SSTI
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksAdherence will be reported on a 5 point scale for child and other family members: 1. \- "I always did the hygiene recommendations/bleach baths/mupirocin as recommended". 2. \- "I sometimes didn't do the hygiene recommendations/bleach baths/mupirocin knowingly or unknowingly, but never omitted more than one time/dose/bath in a row" 3. \- "I sometimes didn't do the hygiene recommendations/bleach baths/mupirocin knowingly or unknowingly, but never omitted more than one day/week in a row" 4. \- "I missed hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly, for two or more days/weeks in a row". 5. \- "I missed most hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly."
Outcome measures
| Measure |
Hygiene Education
n=5 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Mean Adherence to Intervention
|
1 score on a scale
Standard Deviation 0
|
1.5 score on a scale
Standard Deviation 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsfrequency of work absences due to child's MRSA infection
Outcome measures
| Measure |
Hygiene Education
n=5 Participants
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 Participants
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Number of Parents Who Missed Work
|
0 Participants
|
1 Participants
|
Adverse Events
Hygiene Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hygiene Education and Decolonization
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hygiene Education
n=5 participants at risk
Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital as outlined here:
* Take daily showers or bath with soap
* Clean hands with soap and water or with hand sanitizers when hands are dirty, and after each bathroom break or diaper change
* Don't share towels, wash cloths, clothing, toothbrushes, or razors within the family or with friends
* Discard lotions in jars (can be easily contaminated with MRSA when someone puts their hand in a jar)
* Keep all wounds including cuts and scrapes clean and covered until healed
* Avoid other person's dirty bandages or uncovered wounds
* Encourage athletes or health club members to shower before and after all practices and competitions, and wipe down equipment surfaces before and after use
* Uniforms and practice jerseys should be washed after each game or practice. Sports equipment should be washed/cleaned weekly
* Wash all towels, wash cloths, sleepwear, underwear, and linens in hot water with laundry detergent once weekly and dry with hot air in a dryer
|
Hygiene Education and Decolonization
n=4 participants at risk
Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite \[Clorox; The Clorox Company\] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupirocin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Nosebleed
|
0.00%
0/5 • 1 year
|
25.0%
1/4 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place