Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Cephalexin; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria

• Must have cellulitis as defined here:

1. Definition A (preferred definition):

Recent onset of soft tissue erythema, considered by the treating clinician to be bacterial in origin, and associated with signs of infection that include at least two of the following: pain, swelling, warmth, fever, lymphangitis, induration, or ulceration.

2. Definition B (ONLY for darkly-pigmented subjects who cannot use Definition A):

Recent onset of soft tissue color change, pain, or swelling, considered by the treating clinician to be bacterial in origin, and at least one of the following: warmth, fever, induration, or ulceration

• Clinical (non-research) attending physician agrees with treatment with cephalexin until 3 days after all symptoms gone, using our weight-based dosing

• Responsible clinical attending physician comfortable with adding trimethoprim-sulfamethoxazole vs. placebo to the above

• Subject understands the study and signs written informed consent.

• Subject agrees to drink at least 1 liter of fluid per day.

• Subject will commit to all follow-up appointments

Exclusion Criteria:

• Age < 12 months or weight <15 kg

• Current skin infection has already been treated

• Allergy to sulfa drugs

• History of severe allergic reaction to penicillin (defined as anaphylactoid reaction, angioedema, bronchospasm)

• Current use of any antibiotic (other than topicals)

• Diabetes mellitus

• Cellulitis complicated by underlying peripheral vascular disease

• Renal insufficiency, defined as patient report, clinical suspicion, or creatinine>1.3 or EGFR<60 on the last-available set of chemistry results in our computer system

• Hospital admission required

• Presence of > 1 cc of purulent discharge at any time

• Cellulitis involving an indwelling vascular, enteric, or urinary catheter

• Immunocompromise of any etiology

• Pregnancy

• Breast feeding

• Facial cellulitis (infection is above the clavicles)

• Cellulitis associated with marine or freshwater injury, or animal or human bite. (Insect bites not excluded.)

• History of glucose-6-phosphate dehydrogenase deficiency

• Taking coumadin (warfarin), methotrexate, cisapride, phenytoin (dilantin), digoxin, or dofetilide

• Known megaloblastic anemia due to folate deficiency.