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| ID | Type | Description | Link |
|---|---|---|---|
| 1R24HS022434-01 | U.S. NIH Grant/Contract | View source |
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Unable to recruit all planned participants prior to end of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hygiene education | Active Comparator | Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital. |
|
| Hygiene education and Decolonization | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hygiene education | Other | Participants will receive specific hygiene instructions according to existing recommendations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Mean Adherence to Intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul I Musey, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33064109 | Derived | Moore CM, Wiehe SE, Lynch DO, Claxton GE, Landman MP, Carroll AE, Musey PI. Methicillin-Resistant Staphylococcus aureus Eradication and Decolonization in Children Study (Part 1): Development of a Decolonization Toolkit With Patient and Parent Advisors. J Particip Med. 2020 May 20;12(2):e14974. doi: 10.2196/14974. | |
| 33064098 | Derived | Moore CM, Wiehe SE, Lynch DO, Claxton GE, Landman MP, Carroll AE, Musey PI. Methicillin-Resistant Staphylococcus aureus Eradication and Decolonization in Children Study (Part 2): Patient- and Parent-Centered Outcomes of Decolonization. J Particip Med. 2020 May 20;12(2):e14973. doi: 10.2196/14973. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with at least 1 study evaluation at 6 weeks, 6 months, or 12 months. | Posted | Count of Participants | Participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nosebleed | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
We enrolled 14 subjects with only 9 completing at least one outcome assessment. This was far below the 118 (total) or 59/arm needed for appropriate statistical analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Musey | Indiana University | (317) 880-3900 | pmusey@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2019 | Feb 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
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| Sodium Hypochlorite | Other | 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 |
|
| Mupirocin ointment | Drug | 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 |
|
Adherence will be reported on a 5 point scale for child and other family members:
| 6 weeks |
| Number of Parents Who Missed Work | frequency of work absences due to child's MRSA infection | 12 months |
| Physician Decision |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Surgical Drainage procedure location | Where the incision and drainage procedure took place (Operating room vs Emergency Department). | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Mean Adherence to Intervention | Adherence will be reported on a 5 point scale for child and other family members:
| Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Number of Parents Who Missed Work | frequency of work absences due to child's MRSA infection | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 1 | 4 |
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| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |