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

Primary Purpose

Cellulitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
trimethoprim-sulfamethoxazole
Cephalexin
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulitis focused on measuring Cellulitis, Bactrim, Trimethoprim Sulfamethoxazole, MRSA, Methicillin-resistant Staphylococcus aureus

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard therapy

Standard plus anti-CA-MRSA

Arm Description

cephalexin plus placebo

cephalexin plus trimethoprim-sulfamethoxazole

Outcomes

Primary Outcome Measures

Relative Efficacy
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
Proportion of subjects in each arm with progression from cellulitis to abscess.

Full Information

First Posted
December 28, 2007
Last Updated
August 12, 2012
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00676130
Brief Title
Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Official Title
Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis
Keywords
Cellulitis, Bactrim, Trimethoprim Sulfamethoxazole, MRSA, Methicillin-resistant Staphylococcus aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
cephalexin plus placebo
Arm Title
Standard plus anti-CA-MRSA
Arm Type
Experimental
Arm Description
cephalexin plus trimethoprim-sulfamethoxazole
Intervention Type
Drug
Intervention Name(s)
trimethoprim-sulfamethoxazole
Other Intervention Name(s)
Bactrim, Co-trimoxazole, Septra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Other Intervention Name(s)
Keflex
Intervention Description
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
Primary Outcome Measure Information:
Title
Relative Efficacy
Description
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.
Time Frame
12 +/- 2 days; 30 +/- 2 days
Secondary Outcome Measure Information:
Title
Progression to Abscess
Description
Proportion of subjects in each arm with progression from cellulitis to abscess.
Time Frame
12 +/- 2 days, 30 days +/- 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Must have cellulitis as defined here: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J. Pallin, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23457080
Citation
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.
Results Reference
derived

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

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