DMID protocol #07-0051 - U of C protocol #16406A - April 2009-2012

Short Name: "MRSA Treatment Study"

Study Objectives:

To determine the optimal management of uncomplicated skin and soft tissue infections (uSSTI) in children and adults in areas where CA-MRSA is prevalent.  Primary objectives include comparing uSSTI's treated with incision and drainage plus either clindamycin (CLINDA) or trimethoprim-sulfamethoxazole (TMP-SMX), or placebo.

Inclusion Criteria:

• Ages 6 months to 85 years (who will not be hospitalized)
• Cellulitis
• Abscess
• Must have > 2 signs or symptoms for at least 24 hours:
  • Erythema
  • Swelling or induration
  • Local warmth
  • Purulent drainage
  • Tenderness or pain upon palpation

Exclusion Criteria:

• Impetigo or ecthyma
• Folliculitis
• Simple boil
• Surgical or catheter sites
• Immunocompromised host (including Diabetes)
• Third trimester pregnancy
• Inpatient hospitalization within past 2 weeks
• Residence at a skilled nursing facility
• Unstable psychiatric condition
• ETOH or other drug abuse
• Concomitant use of warfarin, phenytoin, methotrexate

*See Protocol Binder in ED for complete information and list of full inclusion and exclusion criteria.  If there are ANY questions, please call study nurses or physicians.

Call Study Nurses to Consent and Enroll Patients

Pager #7234 or 1-877-677-2236

9am - 9pm Mon-Fri

Diana Sullivan, RN, BSN or Tracey Silverstein, RN, BSN

Principal Investigator and Sub-Investigators:

PI: Robert S. Daum, MD, CM

Adult ED: Robert Mulliken, MD and Janis Tupesis, MD

Comer ED: Alison Tothy, MD and Maggie Paik, MD

Sub-I: Stephen Weber, MD