Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cellulitis
Intervention: Cephalexin + Trimethoprime Sulfamethoxazole (Drug); Cephalexin/Dicloxacillin + Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Daniel J. Pallin, MD, MPH, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
Daniel J. Pallin, MD, MPH, Phone: 617-732-5500, Email: dpallin@partners.org
Summary
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.
Clinical Details
Official title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Daniel J. Pallin, MD, MPH, Phone: 617-732-5500, Email: dpallin@partners.org
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Daniel J. Pallin, MD, MPH, Principal Investigator
Additional Information
Starting date: May 2007
Ending date: October 2010
Last updated: September 15, 2009
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