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Sponsored by: |
Brigham and Women's Hospital |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00676130 |
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.
Condition | Intervention |
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Cellulitis |
Drug: Cephalexin + Trimethoprime Sulfamethoxazole Drug: Cephalexin/Dicloxacillin + Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients |
Estimated Enrollment: | 279 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Placebo Comparator |
Drug: Cephalexin/Dicloxacillin + Placebo
Weight-based dosing in capsule form according to the following scale: 60 kg (132 lbs): Celphalexin 500 mg 4x/day; Dicloxacillin 250 mg 4x/day 60-80 kg (132-176 lbs): Cephalexin 1000 mg 3x/day; Dicloxacillin 500 mg 3x/day > 80 kg (176 lbs): Cephalexin 1000 mg 4x/day; Dicloxacillin 500 mg 4x/day |
II: Experimental |
Drug: Cephalexin + Trimethoprime Sulfamethoxazole
Weight-based dosing in capsule form according to the following scale: 60 kg (132 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 80/400 mg 4x/day; Celphalexin 500 mg 4x/day 60-80 kg (132-176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 3x/day; Cephalexin 1000 mg 3x/day > 80 kg (176 lbs): Trimethoprim Sulfamethoxazole (Bactrim) 160/800 mg 4x/day; Cephalexin 1000 mg 4x/day |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel J. Pallin, MD, MPH | 617-732-5500 | dpallin@partners.org |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Daniel J. Pallin, MD, MPH |
Principal Investigator: | Daniel J. Pallin, MD, MPH | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Daniel J. Pallin, MD, MPH ) |
Study ID Numbers: | 2007P000414, F8349839 |
Study First Received: | December 28, 2007 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00676130 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cellulitis Bactrim Trimethoprim Sulfamethoxazole MRSA Methicillin-resistant Staphylococcus aureus |
Trimethoprim Dicloxacillin Sulfamethoxazole Skin Diseases Cephalexin Anti-Infective Agents, Urinary Trimethoprim-Sulfamethoxazole Combination Folic Acid Antagonists Inflammation |
Folic Acid Antimalarials Anti-Bacterial Agents Cellulitis Skin Diseases, Infectious Methicillin Connective Tissue Diseases Emergencies Suppuration |
Anti-Infective Agents Trimethoprim Disease Attributes Antiprotozoal Agents Dicloxacillin Molecular Mechanisms of Pharmacological Action Cephalexin Trimethoprim-Sulfamethoxazole Combination Infection Renal Agents Anti-Bacterial Agents Antimalarials Cellulitis |
Antiparasitic Agents Pathologic Processes Therapeutic Uses Connective Tissue Diseases Suppuration Sulfamethoxazole Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Inflammation Skin Diseases, Infectious Emergencies |