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

August 12, 2012 updated by: Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Keflex
Experimental: Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
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 Names:
  • Keflex
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:
  • Co-trimoxazole
  • Bactrim
  • Septra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 +/- 2 days; 30 +/- 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to Abscess
Time Frame: 12 +/- 2 days, 30 days +/- 2 days
Proportion of subjects in each arm with progression from cellulitis to abscess.
12 +/- 2 days, 30 days +/- 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Daniel J. Pallin, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

May 8, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 12, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000414
  • F8349839

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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