Clinical trial NCT02690415: Community-Assoc. S. Aureus Colonization and Recurrent Infection in Pts With Uncomplicated S. Aureus Skin Abscesses
Official title: Effect of Antibiotics on Community-Associated Staphylococcus Aureus Colonization and Recurrent Infection in Patients With Uncomplicated S. Aureus Skin Abscesses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MRSA
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2016-02-24
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Methicillin-resistant Staphylococcus aureus (MRSA) was once associated almost exclusively with healthcare-associated infections. However, new epidemic strains have emerged outside of the healthcare environment designated community-associated (CA) MRSA. From 1999 to 2005, hospitalizations for Staphylococcus aureus-related skin and soft tissue infections (SSTI) in the United States increased 4-fold to nearly 90,000 annually. At Memorial Medical Center (MMC) Emergency Department (ED) and Express Cares (EC) there have been over 6500 visits in the last 6 years secondary to SSTI.

Current Infectious Diseases Society of America (IDSA) guidelines suggest incision and drainage alone (without antibiotics) may be adequate management for uncomplicated MRSA skin abscesses. However, patients not receiving antibiotics are more likely to develop recurrent infections, which may be a result of persistent MRSA colonization. The investigators will conduct a prospective case-control study at MMC ED, EC and MMC primary care clinics of pediatric patients with skin abscesses comparing outcomes for those who received antibiotics (cases) versus those who did not (controls). This will not be an intervention study - both surgical and medical management of patients with skin abscesses will be at the discretion of the treating physician.

The central hypothesis is that the inclusion of systemic antibiotics in the management of S. aureus skin abscesses will decrease S. aureus colonization, and subsequently the incidence of recurrent SSTI in the year following baseline infection. To gain a better understanding of this problem, the investigators propose the following specific aims:

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Determine if there is a change in colonization status from baseline
timeFrame: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
measure: Measure incidence of recurrent SSTI
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
measure: Measure S. aureus antibiotic resistance in patients who did and did not receive antibiotics
timeFrame: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
Other outcomes:
Locations:
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
Study officials:
affiliation: SIU School of Medicine
name: Marcela Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogan, Patrick G., et al.