Pharmacokinetics of intraperitoneal and intravenous fosfomycin in automated peritoneal dialysis patients without peritonitis

Phase 1

Conditions: 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: 9.1Level: LLTClassification code 10034660Term: Peritoneal dialysis

Registration Number: EUCTR2009-011505-16-AT

Lead Sponsor: Medizinische Universität Wien,KIM I,Klinische Abteilung für Infektionen u.Tropenmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 8

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Determination of concentrations of fosfomycin in plasma and dialysate after single intraperitoneal or intravenous application in APD-patients<br><br> ;Secondary Objective: 2. Calculation of PK/PD indices to estimate target site efficacy of fosfomycin. <br>;Primary end point(s): AUC, Cmax, Half-life (t1/2), time to reach maximum drug concentration (tmax)

Secondary Outcome Measures