MRSA
Conditions
Brief summary
In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.
Detailed description
The past two decades have seen a dramatic increase in skin and soft tissue infections (SSTI) caused by antibiotic resistant bacteria Methicillin-resistant Staphylococcus aureus (MRSA). The shift from hospital-acquired infections to community-acquired infections has resulted in many otherwise healthy children being affected. Recent estimates are that the US incidence of hospitalizations caused by MRSA SSTI is \> 45 per 100,000 children, with many children requiring surgical procedures to drain pus caused by the infection. Treatment of MRSA SSTI usually involves abscess surgery (incision and drainage), but recurrence of infection can be as high as 72%. Decolonization protocols are, therefore, sometimes recommended to eradicate the bacteria and decrease recurrence. These measures can be burdensome for the patient, consisting of regular bleach baths or chlorhexidine body washes, and/or daily nasal antibiotics. The Infectious Disease Society of America supports decolonization, but acknowledges that the recommendations are based on limited, non-MRSA specific data. One small, randomized controlled trial of children with Staphylococcus aureus infection (MRSA and non MRSA) has shown a short lasting effect (4 months) on skin colonization (presence of bacteria on the skin), and an even shorter lasting effect (1 month) on SSTI recurrence. The effect of decolonization on patient-centered outcomes such as quality of life and school attendance has not been assessed. In this study, the investigators intend to compare therapies (abscess surgery and hygiene education compared to abscess surgery and hygiene education followed by decolonization) for Methicillin-Resistant Staphylococcus Aureus skin and soft tissue infections (MRSA SSTI) to determine which is the more effective treatment. The investigators focus on patient centered outcomes as described by the families of MRSA infected patients. Such outcomes are likely to include quality of life, side effects, and school and work attendance. The hypothesis is that treatment with decolonization will decrease the rate of SSTI recurrence and improve overall patient centered outcomes. The rationale is that negative outcomes such as recurrence may be avoided through the use of readily available prevention strategies, but that it is important to determine how burdensome those prevention strategies are for patients and families.
Interventions
OTHERHygiene education
Participants will receive specific hygiene instructions according to existing recommendations.
OTHERSodium Hypochlorite
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 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
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children/youth ages 3 months - 18 years seen in the Riley Pediatric Surgery Outpatient Clinic for a follow up visit within two weeks of the incision and drainage of a culture-confirmed MRSA abscess (regardless of where the abscess was drained) * Children/youth ages 3 months - 18 years who had an incision and drainage of a culture-confirmed MRSA abscess in the Riley Emergency Department or Riley Operating Room within the two weeks prior to enrollment * Household members of the patient who are between the ages 3 months - 64 years
Exclusion criteria
* Children in need of additional abscess surgery * Documented immune deficiency * Previous burn victims * Self reported history of sensitivity to chlorine bleach or mupirocin * Families without a bathtub
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection | 12 months | Interval 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Missed School Due to MRSA SSTI | 12 months | Parents 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. |
| Mean Adherence to Intervention | 6 weeks | Adherence 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. |
| Number of Parents Who Missed Work | 12 months | frequency of work absences due to child's MRSA infection |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Screen Fail (Not MRSA on culture check) | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Hygiene Education | Total | Hygiene Education and Decolonization |
|---|---|---|---|
| Age, Continuous | 3.6 years STANDARD_DEVIATION 2.81 | 3.5 years STANDARD_DEVIATION 3.61 | 3.5 years STANDARD_DEVIATION 4.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
| Surgical Drainage procedure location Emergency Department | 1 Participants | 3 Participants | 2 Participants |
| Surgical Drainage procedure location Operating Room | 6 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 1 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI)
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.
Time frame: 12 months
Population: Participants with at least 1 study evaluation at 6 weeks, 6 months, or 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hygiene Education | Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI) | 1 Participants |
| Hygiene Education and Decolonization | Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI) | 2 Participants |
Secondary
Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection
Interval 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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hygiene Education | Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection | 0 Participants |
| Hygiene Education and Decolonization | Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection | 2 Participants |
Other Pre-specified
Mean Adherence to Intervention
Adherence 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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hygiene Education | Mean Adherence to Intervention | 1 score on a scale | Standard Deviation 0 |
| Hygiene Education and Decolonization | Mean Adherence to Intervention | 1.5 score on a scale | Standard Deviation 1 |
Other Pre-specified
Number of Parents Who Missed Work
frequency of work absences due to child's MRSA infection
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hygiene Education | Number of Parents Who Missed Work | 0 Participants |
| Hygiene Education and Decolonization | Number of Parents Who Missed Work | 1 Participants |
Other Pre-specified
Participants Who Missed School Due to MRSA SSTI
Parents 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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hygiene Education | Participants Who Missed School Due to MRSA SSTI | 0 Participants |
| Hygiene Education and Decolonization | Participants Who Missed School Due to MRSA SSTI | 0 Participants |