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Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
This study is currently recruiting participants.
Verified by Brigham and Women's Hospital, May 2008
First Received: December 28, 2007   Last Updated: May 8, 2008   History of Changes
Sponsored by: Brigham and Women's Hospital
Information provided by: Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00676130
  Purpose

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.


Condition Intervention
Cellulitis
Drug: Cephalexin + Trimethoprime Sulfamethoxazole
Drug: Cephalexin/Dicloxacillin + Placebo

MedlinePlus related topics: Cellulitis
Drug Information available for: Dicloxacillin sodium Cephalexin Cephalexin hydrochloride Sulfamethoxazole Trimethoprim Dicloxacillin Trimethoprim-sulfamethoxazole combination
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 279
Study Start Date: May 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Placebo Comparator Drug: Cephalexin/Dicloxacillin + Placebo

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

60 kg (132 lbs): Celphalexin 500 mg 4x/day; Dicloxacillin 250 mg 4x/day

60-80 kg (132-176 lbs): Cephalexin 1000 mg 3x/day; Dicloxacillin 500 mg 3x/day

> 80 kg (176 lbs): Cephalexin 1000 mg 4x/day; Dicloxacillin 500 mg 4x/day

II: Experimental Drug: Cephalexin + Trimethoprime Sulfamethoxazole

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

60 kg (132 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 80/400 mg 4x/day; Celphalexin 500 mg 4x/day

60-80 kg (132-176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 3x/day; Cephalexin 1000 mg 3x/day

> 80 kg (176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 4x/day; Cephalexin 1000 mg 4x/day


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult >= 18 years
  2. Confirmed cellulitis according to the following definition: a) soft-tissue erythema of recent onset (within one week); b) infectious in origin; c) at least one of the following: warmth, fever, lymphangitis, induration, ulceration, pain

Exclusion Criteria:

  1. Facial cellulitis
  2. Current use of any antibiotic
  3. Infection has been previously treated
  4. Sulfa allergy
  5. History of severe allergic reaction to penicillin
  6. History of G6PD deficiency
  7. Taking coumadin (warfarin), methotrexate, cisapride, or dofetilide
  8. Patient has been diagnosed with renal insufficiency
  9. History of diabetes mellitus
  10. Cellulitis associated with marine or freshwater injury, or animal or human bite (Insect bites are okay for this study).
  11. Pregnancy and/or Breast feeding
  12. Admission to the hospital
  13. Abscess yielding > 1 cc of pus
  14. Cellulitis involves an indwelling vascular, enteric, or urinary catheter
  15. Immunocompromise of any etiology
  16. Known megaloblastic anemia due to folate deficiency
  17. Cellulitis complicated by underlying peripheral vascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676130

Contacts
Contact: Daniel J. Pallin, MD, MPH 617-732-5500 dpallin@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Daniel J. Pallin, MD, MPH            
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Daniel J. Pallin, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Brigham and Women's Hospital ( Daniel J. Pallin, MD, MPH )
Study ID Numbers: 2007P000414, F8349839
Study First Received: December 28, 2007
Last Updated: May 8, 2008
ClinicalTrials.gov Identifier: NCT00676130     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Cellulitis
Bactrim
Trimethoprim Sulfamethoxazole
MRSA
Methicillin-resistant Staphylococcus aureus

Study placed in the following topic categories:
Trimethoprim
Dicloxacillin
Sulfamethoxazole
Skin Diseases
Cephalexin
Anti-Infective Agents, Urinary
Trimethoprim-Sulfamethoxazole Combination
Folic Acid Antagonists
Inflammation
Folic Acid
Antimalarials
Anti-Bacterial Agents
Cellulitis
Skin Diseases, Infectious
Methicillin
Connective Tissue Diseases
Emergencies
Suppuration

Additional relevant MeSH terms:
Anti-Infective Agents
Trimethoprim
Disease Attributes
Antiprotozoal Agents
Dicloxacillin
Molecular Mechanisms of Pharmacological Action
Cephalexin
Trimethoprim-Sulfamethoxazole Combination
Infection
Renal Agents
Anti-Bacterial Agents
Antimalarials
Cellulitis
Antiparasitic Agents
Pathologic Processes
Therapeutic Uses
Connective Tissue Diseases
Suppuration
Sulfamethoxazole
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Inflammation
Skin Diseases, Infectious
Emergencies

ClinicalTrials.gov processed this record on May 07, 2009