Clinical trial NCT02127658: MRSA Eradication and Decolonization in Children
Official title: MRSA Eradication and Decolonization in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: MRSA
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 14
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Recurrence of Skin and Soft Tissue Infection (SSTI)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Undergoing Repeat Surgery or Incision/Drainage Procedure for Skin and Soft Tissue Infection
timeFrame: 12 months
Other outcomes:
measure: Participants Who Missed School Due to MRSA SSTI
timeFrame: 12 months
measure: Mean Adherence to Intervention
timeFrame: 6 weeks
measure: Number of Parents Who Missed Work
timeFrame: 12 months
Locations:
city: Indianapolis
country: United States
facility: Pediatric Surgery Outpatient Clinic, Riley Outpatient Center, Riley Hospital for Children, Indiana University Health
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Paul I Musey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.