Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00676130 |
Recruitment Status :
Completed
First Posted : May 12, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
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Sponsor:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Cellulitis |
Interventions |
Drug: trimethoprim-sulfamethoxazole Drug: Cephalexin |
Enrollment | 153 |
Participant Flow
Recruitment Details | We enrolled generally-healthy subjects with uncomplicated acute cellulitis from 6/2007 to 12/2011. Eligible subjects were adults and children presenting to EDs of 3 teaching hospitals in Boston, MA. |
Pre-assignment Details | Each subject was assigned randomly to a treatment group by the institutions' research pharmacies. The research pharmacies had no knowledge of subjects' clinical characteristics. Treating (non-research) clinicians, research clinicians, coordinators, and subjects had no knowledge of the randomization sequence. |
Arm/Group Title | Trimethoprim-sulfamethoxazole | Placebo |
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Cephalexin plus trimethoprim-sulfamethoxazole | Cephalexin plus placebo |
Period Title: Overall Study | ||
Started | 76 | 77 |
Completed | 73 | 73 |
Not Completed | 3 | 4 |
Reason Not Completed | ||
Lost to Follow-up | 0 | 1 |
Found ineligible | 3 | 2 |
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Trimethoprim-sulfamethoxazole | Placebo | Total | |
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Cephalexin plus trimethoprim-sulfamethoxazole | Cephalexin plus placebo | Total of all reporting groups | |
Overall Number of Baseline Participants | 76 | 77 | 153 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 76 participants | 77 participants | 153 participants | |
<=18 years |
3 3.9%
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5 6.5%
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8 5.2%
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Between 18 and 65 years |
68 89.5%
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69 89.6%
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137 89.5%
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>=65 years |
5 6.6%
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3 3.9%
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8 5.2%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 76 participants | 77 participants | 153 participants | |
37.03 (15.07) | 32.43 (15.15) | 34.71 (15.23) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 76 participants | 77 participants | 153 participants | |
Female |
39 51.3%
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36 46.8%
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75 49.0%
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Male |
37 48.7%
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41 53.2%
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78 51.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 76 participants | 77 participants | 153 participants |
76 | 77 | 153 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Daniel J. Pallin, MD, MPH |
Organization: | Brigham and Women's Hospital |
Phone: | 617-525-6614 |
EMail: | dpallin@partners.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00676130 |
Other Study ID Numbers: |
2007P000414 F8349839 |
First Submitted: | December 28, 2007 |
First Posted: | May 12, 2008 |
Results First Submitted: | July 3, 2012 |
Results First Posted: | August 14, 2012 |
Last Update Posted: | August 14, 2012 |