A group of adult male or female patients with documented diabetes and bacterial soft tissue infection of the foot who must be subjected to undergo intravenous antimicrobial therapy with broad spectrum antibiotics.
Conditions
Sponsors
Medical University Graz, Department for Plastic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study. 2. Male or female patient of 18 years of age or older. 3. Patient suffers from documented diabetes and soft tissue infection of the lower limb. 4. Requires intravenous broad-spectrum anti-microbial therapy 5. CRP higher than 5 mg/dl at baseline 6. Patient has no relevant renal dysfunction indicated by a creatinine clearance =40 ml/min as determined by the Cockcroft-Gault equation using actual body weight 7. Negative urine pregnancy test in females of childbearing potential 8. Patient is willing to participate in the study, follow protocol study treatment regimen, and comply with all planned assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with the study drug within the past three weeks prior to study enrolment. 2. Site of infection other than infection of the lower limb 3. History of hypersensitivity to the study drug 4. Patients submitted to the hospital with known pathogens resistant to study drug. 5. Patient with a neutrophils count <1000/mm3. 6. Use of any other investigational therapy at the time of enrolment, or within 30 days or 5 half-lives before inclusion into, whichever is longer. 7. Patients unable or unwilling to adhere to the study-designated procedures and restrictions. 8. Unable to understand the nature, purpose and extent of the study 9. Nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the pharmacokinetic profile of daptomycin in inflamed subcutaneous adipose tissue in diabetic foot infection at steady state after once daily intravenous administration of 6 mg/kg.;Secondary Objective: - To evaluate the pharmacokinetic profiles of daptomycin in non-inflamed subcutaneous adipose tissue and in plasma - To compare the pharmacokinetic profiles of daptomycin in inflamed soft tissue, healthy soft tissue, and plasma ;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed