A group of adult male or female patients with documented necrotizing soft tissue infection who must be subjected to undergo intravenous antimicrobial therapy with broad spectrum antibiotics.
Conditions
Interventions
Trade Name: Cubicin 350 mg powder for solution for injection or infusion
Product Name: Cubicin (Daptomycin)
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Daptomycin
CAS Number: 103060
Sponsors
Medizinische Universität Graz - Abteilung für Thorax- und Hyperbare Chirurgie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with severe necrotizing soft tissue infections 2. Normal blood clotting 3. Negative pregnancy test in females of childbearing potential 4. Negative HIV test 5. Negative Hepatitis-Serology 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. Pregnancy, Lactation 2. Ongoing Cortisone therapy 3. Serum creatine > 1.8 mg/dl 4. Gaseous gangrene ("Clostridial Myonecrosis") 5. Patients submitted to the hospital with known pathogens resistant to study drug 6. Creatinine-Clearance < 40ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetic profile of daptomycin and fosfomycin in infected and healthy skeletal muscle as well as subcutaneous fat tissue of patients with necrotizing soft tissue infections.;Secondary Objective: ;Primary end point(s): Pharmacokinetic parameters of Daptomycin and Fosfomycin | — |
Countries
Austria
Outcome results
None listed