Community-Assoc. S. Aureus Colonization and Recurrent Infection in Pts With Uncomplicated S. Aureus Skin Abscesses

NCT02690415 | Completed

• 1 other identifier: ROD-SIU-14-197-CIRCUS
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Infections due to S. aureus are a major healthcare burden. Currently there is not an effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines suggest that incision and drainage alone may be adequate for management of uncomplicated CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is not known whether antibiotics are helpful in decreasing S. aureus colonization rates or preventing future S. aureus infections. Though resolution of acute abscess after drainage may be unchanged by antibiotic administration, the impact of managing S. aureus abscess without antibiotics on ongoing S. aureus colonization and recurrent infection requires further study. This study seeks to examine whether the management of initial S. aureus abscesses with incision and drainage in addition to antibiotic therapy is an effective means of preventing recurrent infection. The prolonged longitudinal follow-up of this study is another unique characteristic that will enable the investigators to capture data about recurrences of infections.

Conditions

MRSA

Outcome Measures

Primary Outcomes (2)

• Determine if there is a change in colonization status from baseline

  To determine S. aureus colonization status at three body sites (nose, axilla and inguinal folds) in pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.

  At the time of surgical incision and drainage of the baseline skin abscess and 1 month post

• Measure incidence of recurrent SSTI

  To measure incidence of recurrent SSTI at 1, 3, 6 and 12 months in patients who did or did not receive antibiotic therapy.

  1, 3, 6 and 12 months

Secondary Outcomes (1)

• Measure S. aureus antibiotic resistance in patients who did and did not receive antibiotics

  At the time of surgical incision and drainage of the baseline skin abscess and 1 month post

Study Arms (2)

Antibiotics Given

Patients who's treating physician prescribed antibiotics following incision and drainage of their abscess.

Procedure: Antibiotics Given; Procedure: Antibiotics not given

Antibiotics Not Given

Patients who's treating physician did not prescribed antibiotics following incision and drainage of their abscess.

Procedure: Antibiotics Given; Procedure: Antibiotics not given

Interventions

Antibiotics Given PROCEDURE

Patients who's treating physician prescribed antibiotics

Antibiotics Given; Antibiotics Not Given

Antibiotics not given PROCEDURE

Patients who's treating physician did not prescribed antibiotics

Antibiotics Given; Antibiotics Not Given

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.

You may qualify if:

• (1) Children 6 months to 18 years presenting with a skin abscess.
• (2) Positive MRSA or MSSA culture from previous or current abscess

You may not qualify if:

• (1) Immunodeficiency;
• (2) Hospitalization within the prior 14 days
• (3) Use of mupirocin, clorhexidine or bleach water baths in the last month
• (4) Systemic antibacterial therapy with anti-staphylococcal activity within the prior 14 days.

Sponsors & Collaborators

• Southern Illinois University: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

SIU School of Medicine

Springfield, Illinois, 62764, United States

Location

Related Publications (1)

• Hogan, Patrick G., et al.

  RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

colonization swabs from the nose, axilla, inguinal folds and wound isolate

Study Officials

• Marcela Rodriguez, MD

  SIU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 24, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)