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

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.
 
ClinicalTrials.gov Identifier: NCT00676130
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE December 28, 2007
First Posted Date  ICMJE May 12, 2008
Results First Submitted Date  ICMJE July 3, 2012
Results First Posted Date  ICMJE August 14, 2012
Last Update Posted Date August 14, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2012)
Progression to Abscess [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ]
Proportion of subjects in each arm with progression from cellulitis to abscess.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Official Title  ICMJE Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cellulitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2012)
153
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2008)
279
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676130
Other Study ID Numbers  ICMJE 2007P000414
F8349839
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel J. Pallin, MD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2012

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