diabetic patients with soft tissue infection, necessiting antibiotic therapy
Conditions
Interventions
Trade Name: Zyvoxid
Pharmaceutical Form: Powder for suspension for injection
Sponsors
Department of Clinical Pharmacology, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, = 18 years old • Diagnosis of Diabetes mellitus • Clinically diagnosed skin or STI and/or infected ulcers of the leg, requiring antimicrobial therapy • Prescription of antibiotic indicated, with Linezolid being an adequate therapy. • Willingness and ability to comply with the protocol • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Allergy or hypersensitivity against study drug. • Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L • Severe hepatic impairment ( Child-Pugh Class C) • Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period • Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The time versus unbound linezolid concentration profiles in the ISF of inflamed tissue and non-inflamed subcutaneous adipose tissue and in plasma of diabetes patients after multiple doses will be determined. The following PK parameters will be determined for all compartments. Main outcome variables: Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax). Secondary outcome variables: ratios of AUC and Cmax of different compartments (inflamed vs. non-inflamed, plasma vs. tissue), time above minimum inhibitory concentrations of linezolid for susceptible bacteria (T>MIC), ratio of Area under the concentration vs. time curve form 0 to 24 hours (AUC0-24)/MIC. ;Main Objective: 1) Determination of concentrations of linezolid in plasma and the ISF of inflamed tissue and non-inflamed s.c. tissue of diabetes patients after a single dose. Tissue concentrations will be related to corresponding unbound plasma concentrations. 2) Determination of concentrations of linezolid in plasma and the ISF of inflamed tissue and non-inflamed s.c. tissue of diabetes patients after multiple doses. Tissue concentrations will be related to corresponding unbound plasma concentrations. 3) To explore, if there is an influence of inflammation on tissue pharmacokinetics of linezolid. 4) Calculation of pharmacokinetic/pharmacodynamic indices to estimate target site efficacy of linezolid. ;Secondary Objective: | — |
Countries
Austria
Outcome results
None listed