Status:
COMPLETED
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Cellulitis
Eligibility:
All Genders
12+ years
Phase:
NA
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, ve...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Must have cellulitis as defined here:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00676130
Start Date
May 1 2007
End Date
May 1 2012
Last Update
August 14 2012
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Children's Hospital Boston
Boston, Massachusetts, United States, 02115