NCT01133600

Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens

Phase IV Study of the Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-Economic Comparison of Daptomycin vs Vancomycin Based Regimens

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Clinical Alliance for Research & Education - Infectious Diseases, LLC. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.

Detailed description

1. to compare the overall economic burden of therapy of a daptomycin vs. a vancomycin based antibiotic regimen for diabetic foot infections in the outpatient setting 2. to compare Quality of Life and patient satisfaction among recipients of a daptomycin vs. a vancomycin based regimen 3. to compare the safety and tolerance (adverse experiences) of daptomycin vs. vancomycin based regimens 4. to compare the efficacy (complete resolution of infection) of daptomycin vs. vancomycin based regimens

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DRUG	Cubicin	dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is \<30ml/min.
DRUG	Vancomycin	dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-05-31
• Last updated: 2013-09-10

Locations

2 sites across 1 country: United States