Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
2 other identifiers
interventional
153
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 28, 2007
CompletedFirst Posted
Study publicly available on registry
May 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
August 14, 2012
CompletedAugust 14, 2012
August 1, 2012
5 years
December 28, 2007
July 3, 2012
August 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 +/- 2 days; 30 +/- 2 days
Secondary Outcomes (1)
Progression to Abscess
12 +/- 2 days, 30 days +/- 2 days
Study Arms (2)
Standard therapy
ACTIVE COMPARATORcephalexin plus placebo
Standard plus anti-CA-MRSA
EXPERIMENTALcephalexin plus trimethoprim-sulfamethoxazole
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 23457080DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel J. Pallin, MD, MPH
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J. Pallin, MD, MPH
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Research Director, Department of Emergency Medicine
Study Record Dates
First Submitted
December 28, 2007
First Posted
May 12, 2008
Study Start
May 1, 2007
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 14, 2012
Results First Posted
August 14, 2012
Record last verified: 2012-08