Penetration of Cubicin® and Fosfomycin® into skeletal muscle and subcutaneous adipose tissue of necrotizing soft tissue infections, measured by in-vivo microdialysis

Conditions: 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.

Registration Number: EUCTR2007-005399-15-AT

Lead Sponsor: Medizinische Universität Graz - Abteilung für Thorax- und Hyperbare Chirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures