MRSA Eradication and Decolonization in Children

MRSA Clinical Trial

— MEDiC  

Official title:

MRSA Eradication and Decolonization in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02127658
• Other study ID #: 1R24HS022434-01, 1305011439
• Secondary ID: 1R24HS022434-01
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: July 2018
• Source: Indiana University
• Contact: Paul I Musey, MD
• Phone: 3178803900
• Email: pmusey[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• MRSA

Intervention

Other:
• Hygiene education
Participants will receive specific hygiene instructions according to existing recommendations.
• 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% mupiricin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days

Locations

Country	Name	City	State
United States	Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	adverse events	6 months
Other	Participant time committed to intervention	The investigators will ask parents to estimate the amount of time (in hours) per week they estimate the intervention took for all family members combined	6 weeks
Other	Quality of Life Quality of Life	Impact on quality of life will be measured by the use of Peds QL, Pediatric Quality of Life Inventory.	12 months
Other	Impact on school attendance	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
Other	Adherence to Intervention	Adherence will be reported on a 5 point scale for child and other family members separately: "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
Other	Impact on parents' work attendance	frequency of work absences due to child's MRSA infection	12 months
Primary	Recurrence of skin and soft tissue infection	frequency of recurrence	12 months
Secondary	Repeat surgery	frequency of repeated surgical procedures	12 months