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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
Clinical Alliance for Research & Education, Infectious Diseases, LlC
Annandale, Virginia, United States
Infuscience
Annandale, Virginia, United States
Pharmaco-economic
Based upon 2 economic parameters associated with the treatment of the infection (provider charges and out-of-pocket costs) from screening until Day 28. Provider charges, as documented in invoices submitted to the pt's. insurance company, will be collected for all activities and services provided by the physician's office,home infusion company, laboratory, etc. during the study period. Out of pocket costs will be captured in a pt. diary and will include any health related costs that are borne by the pt. during the study period. Costs and charges will be analyzed and reported separately.
Time frame: 28 days
Quality of Life/patient satisfaction
QOL and pt. satisfaction with the medication, the clinical care, and the overall experience of the infection and its therapy are captured using three study intstruments, which are described in more detail in the Data Collection Instruments section. These include two validated, standardized QOL instruments administred at Baseline, at two weeks and again at 4 weeks, and a pt. satisfaction survey administered at Baseline, 2 and 4 weeks.
Time frame: 28 days
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