Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
NCT ID: NCT00676130
Last Updated: 2012-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2007-05-31
2012-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard therapy
cephalexin plus placebo
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
Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
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
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
12 Months
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Daniel Jay Pallin, MD, MPH
Associate Research Director, Department of Emergency Medicine
Principal Investigators
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Daniel J. Pallin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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F8349839
Identifier Type: -
Identifier Source: secondary_id
2007P000414
Identifier Type: -
Identifier Source: org_study_id