MRSA Eradication and Decolonization in Children

NCT02127658 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 1R24HS022434-01, 13050114391R24HS022434-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection

  12 months

Other Outcomes (3)

• Participants Who Missed School Due to MRSA SSTI

  12 months

• Mean Adherence to Intervention

  6 weeks

• Number of Parents Who Missed Work

  12 months

Study Arms (2)

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.

Other: Hygiene education

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

Other: Sodium Hypochlorite; Drug: Mupirocin ointment

Interventions

Hygiene education OTHER

Participants will receive specific hygiene instructions according to existing recommendations.

Hygiene education

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

Hygiene education and Decolonization

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

Hygiene education and Decolonization

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• 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.

  PMID: 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 2): Patient- and Parent-Centered Outcomes of Decolonization. J Particip Med. 2020 May 20;12(2):e14973. doi: 10.2196/14973.

  PMID: 33064098 DERIVED

MeSH Terms

Interventions

Sodium Hypochlorite

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Paul Musey
• Organization: Indiana University

pmusey@iu.edu

(317) 880-3900

Study Officials

• Paul I Musey, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Emergency Medicine

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: February 18, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)