A total of 8 patients with renal insufficiency and treatment with automated peritoneal dialysis (APD) will be enrolled into this study evaluating the pharmacokinetics of fosfomycin in this special patient group. MedDRA version: 9.1 Level: LLT Classification code 10034660 Term: Peritoneal dialysis
Conditions
Interventions
Trade Name: Fosfomycin
Product Name: Fosfomycin
Pharmaceutical Form: Powder for infusion*
Sponsors
Medizinische Universität Wien,KIM I,Klinische Abteilung für Infektionen u.Tropenmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, aged between 18 and 85 years • Patients on APD using Icodextrin (Extraneal) for the long daytime dwell • 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) 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: • any systemic infection • peritonitis or catheter-related infection which required antibiotic treatment within 2 months prior to the start of the study . • Allergy or hypersensitivity against study drug. • 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 |
|---|---|
| Main Objective: 1. Determination of concentrations of fosfomycin in plasma and dialysate after single intraperitoneal or intravenous application in APD-patients ;Secondary Objective: 2. Calculation of PK/PD indices to estimate target site efficacy of fosfomycin. ;Primary end point(s): AUC, Cmax, Half-life (t1/2), time to reach maximum drug concentration (tmax) | — |
Countries
Austria
Outcome results
None listed