N/A
N=153
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Cellulitis
Bottom Line
View on ClinicalTrials.gov: NCT00676130 ↗Enrolled (actual)
153
Serious AEs
0.7%
Results posted
Aug 2012
Primary outcome: Primary: Relative Efficacy — 62; 60 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- trimethoprim-sulfamethoxazole (Drug); Cephalexin (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Efficacy |
62; 60 | <0.05 sig |
| SECONDARY Progression to Abscess |
5; 5 | <0.05 sig |
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.
Eligibility Criteria
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 1.3 or EGFR 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.
Data sourced from ClinicalTrials.gov (NCT00676130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.