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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00676130
First received: December 28, 2007
Last updated: August 12, 2012
Last verified: August 2012
  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: trimethoprim-sulfamethoxazole
Drug: Cephalexin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Relative Efficacy [ Time Frame: 12 +/- 2 days; 30 +/- 2 days ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Progression to Abscess [ Time Frame: 12 +/- 2 days, 30 days +/- 2 days ] [ Designated as safety issue: No ]
    Proportion of subjects in each arm with progression from cellulitis to abscess.


Enrollment: 153
Study Start Date: May 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard therapy
cephalexin plus placebo
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
Experimental: Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
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

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676130

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
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 by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Jay Pallin, MD, MPH, Associate Research Director, Department of Emergency Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00676130     History of Changes
Other Study ID Numbers: 2007P000414, F8349839
Study First Received: December 28, 2007
Results First Received: July 3, 2012
Last Updated: August 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 23, 2014