Clinical trial NCT00676130: Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Official title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cellulitis
Keywords: Cellulitis
Bactrim
Trimethoprim Sulfamethoxazole
MRSA
Methicillin-resistant Staphylococcus aureus
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 153
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Relative Efficacy
timeFrame: 12 +/- 2 days; 30 +/- 2 days
Secondary outcomes:
measure: Progression to Abscess
timeFrame: 12 +/- 2 days, 30 days +/- 2 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Daniel J. Pallin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pallin DJ, Binder WD, Allen MB, Lederman M, Parmar S, Filbin MR, Hooper DC, Camargo CA Jr. Clinical trial: comparative effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone for treatment of uncomplicated cellulitis: a randomized controlled trial. Clin Infect Dis. 2013 Jun;56(12):1754-62. doi: 10.1093/cid/cit122. Epub 2013 Mar 1.