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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

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.

Arm && Interventions

Group	Intervention	Description
Standard therapy	Cephalexin	cephalexin plus placebo
Standard plus anti-CA-MRSA	trimethoprim-sulfamethoxazole	cephalexin plus trimethoprim-sulfamethoxazole
Standard plus anti-CA-MRSA	Cephalexin	cephalexin plus trimethoprim-sulfamethoxazole

Primary Outcome Measures

Name	Time	Method
Relative Efficacy	12 +/- 2 days; 30 +/- 2 days	Proportion of subjects in each arm with successful treatment. Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.

Secondary Outcome Measures

Name	Time	Method
Progression to Abscess	12 +/- 2 days, 30 days +/- 2 days	Proportion of subjects in each arm with progression from cellulitis to abscess.

Locations (3): Brigham and Women's Hospital
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Boston, Massachusetts, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Children's Hospital Boston
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Boston, Massachusetts, United States