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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676130
First Posted: May 12, 2008
Last Update Posted: August 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
December 28, 2007
May 12, 2008
July 3, 2012
August 14, 2012
August 14, 2012
May 2007
May 2012   (Final data collection date for primary outcome measure)
Relative Efficacy [ Time Frame: 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.

The main outcome measure will be the relative efficacy of treatment in the two treatment arms: (a) standard therapy plus Bactrim, (b) standard therapy plus placebo. [ Time Frame: 14 days; 30 days ]
Complete list of historical versions of study NCT00676130 on ClinicalTrials.gov Archive Site
Progression to Abscess [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]
Proportion of subjects in each arm with progression from cellulitis to abscess.
Not Provided
Not Provided
Not Provided
 
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cellulitis
  • Drug: trimethoprim-sulfamethoxazole

    Weight-based dosing in capsule or suspension form according to the following scale:

    15-19 kg (33-42 lbs): trimethoprim-sulfamethoxazole 40/200 mg four times daily

    20-24 kg (42-53 lbs): trimethoprim-sulfamethoxazole 60/300 mg four times daily

    25-29 kg (53-64 lbs): trimethoprim-sulfamethoxazole 72/360 mg four times daily

    29-60 kg (64-132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily

    60 kg (132 lbs): trimethoprim-sulfamethoxazole 80/400 mg four times daily

    60-80 kg (132-176 lbs): trimethoprim-sulfamethoxazole 160/800 mg three times daily

    > 80 kg (176 lbs): trimethoprim-sulfamethoxazole 160/800 mg four times daily

    Other Names:
    • Bactrim
    • Co-trimoxazole
    • Septra
  • Drug: Cephalexin

    Weight-based dosing in capsule or suspension form according to the following scale:

    15-19 kg (33-42 lbs): Cephalexin 300 mg four times daily

    20-24 kg (42-53 lbs): Cephalexin 400 mg four times daily

    25-29 kg (53-64 lbs): Cephalexin 500 mg four times daily

    29-60 kg (64-132 lbs): Cephalexin 500 mg four times daily

    60-80 kg (132-176 lbs): Cephalexin 1000 mg three times daily

    > 80 kg (176 lbs): Cephalexin 1000 mg four times daily

    Other Name: Keflex
  • Active Comparator: Standard therapy
    cephalexin plus placebo
    Intervention: Drug: Cephalexin
  • Experimental: Standard plus anti-CA-MRSA
    cephalexin plus trimethoprim-sulfamethoxazole
    Interventions:
    • Drug: trimethoprim-sulfamethoxazole
    • Drug: Cephalexin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
May 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00676130
2007P000414
F8349839
No
Not Provided
Not Provided
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Daniel J. Pallin, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP