Official Title: “Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients”

The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.

The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2010

Intervention(s) in this Clinical Trial

• Drug: Cephalexin + Trimethoprime Sulfamethoxazole
  • Weight-based dosing in capsule form according to the following scale: 60 kg (132 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 80/400 mg 4x/day; Celphalexin 500 mg 4x/day 60-80 kg (132-176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 3x/day; Cephalexin 1000 mg 3x/day > 80 kg (176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 4x/day; Cephalexin 1000 mg 4x/day
• Drug: Cephalexin/Dicloxacillin + Placebo
  • Weight-based dosing in capsule form according to the following scale: 60 kg (132 lbs): Celphalexin 500 mg 4x/day; Dicloxacillin 250 mg 4x/day 60-80 kg (132-176 lbs): Cephalexin 1000 mg 3x/day; Dicloxacillin 500 mg 3x/day > 80 kg (176 lbs): Cephalexin 1000 mg 4x/day; Dicloxacillin 500 mg 4x/day

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: I
• Experimental: II

Primary Measures

• The main outcome measure will be the relative efficacy of treatment in the two treatment arms: (a) standard therapy plus Bactrim, (b) standard therapy plus placebo.
  • Time Frame: 14 days; 30 days
    Safety Issue?: No

Inclusion Criteria:

• 1. Adult >= 18 years
• 2. Confirmed cellulitis according to the following definition: a) soft-tissue erythema of recent onset (within one week); b) infectious in origin; c) at least one of the following: warmth, fever, lymphangitis, induration, ulceration, pain

Exclusion Criteria:

• 1. Facial cellulitis
• 2. Current use of any antibiotic
• 3. Infection has been previously treated
• 4. Sulfa allergy
• 5. History of severe allergic reaction to penicillin
• 6. History of G6PD deficiency
• 7. Taking coumadin (warfarin), methotrexate, cisapride, or dofetilide
• 8. Patient has been diagnosed with renal insufficiency
• 9. History of diabetes mellitus
• 10. Cellulitis associated with marine or freshwater injury, or animal or human bite (Insect bites are okay for this study).
• 11. Pregnancy and/or Breast feeding
• 12. Admission to the hospital
• 13. Abscess yielding > 1 cc of pus
• 14. Cellulitis involves an indwelling vascular, enteric, or urinary catheter
• 15. Immunocompromise of any etiology
• 16. Known megaloblastic anemia due to folate deficiency
• 17. Cellulitis complicated by underlying peripheral vascular disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Brigham and Women's Hospital

Overall Clinical Trial Officials and Contacts

Daniel J. Pallin, MD, MPH Principal Investigator Brigham and Women's Hospital  

Overall Contact: Daniel J. Pallin, MD, MPH 617-732-5500 dpallin@partners.org

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00676130

Study ID Number: 2007P000414

ClinicalTrials.gov Identifier: NCT00676130

Health Authority: United States: Institutional Review Board