NCT00676130

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cellulitis

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2007-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-05-12
• Last updated: 2012-08-14
• Results posted: 2012-08-14

Locations

3 sites across 1 country: United States