MRSA Eradication and Decolonization in Children (MEDiC)

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.

Study Overview

• Status: Terminated
• Conditions: MRSA
• Intervention / Treatment: Other: Hygiene education; Other: Sodium Hypochlorite; Drug: Mupirocin ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hygiene education; Participants will receive specific hygiene instructions according to existing recommendations from the Ryan White Center for Pediatric Infectious Disease, Riley Hospital.	Other: Hygiene education; Participants will receive specific hygiene instructions according to existing recommendations.
Active Comparator: 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	Other: Sodium 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; Drug: Mupirocin ointment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	Adherence will be reported on a 5 point scale for child and other family members: - "I always did the hygiene recommendations/bleach baths/mupirocin as recommended".; - "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"; - "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"; - "I missed hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly, for two or more days/weeks in a row".; - "I missed most hygiene recommendations/bleach baths/mupirocin, knowingly or unknowingly."	6 weeks
Number of Parents Who Missed Work	frequency of work absences due to child's MRSA infection	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Paul I Musey, MD, Indiana University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimated): May 1, 2014

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Disinfectants; Mupirocin; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: 1R24HS022434-01, 1305011439; 1R24HS022434-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No