Healthy volunteers MedDRA version: 18.1 Level: LLT Classification code 10024981 Term: Lower urinary tract infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Monuril
Product Name: Monuril 3000, granulaat voor drank 3 g
Product Code: RVG 13066/7
Pharmaceutical Form: Granules for oral solution in sachet
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - female - age of al least 18 years old 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - male - menstruation during the study week - any kind of infectious disease which is treated during the study week - use of metoclopramide - preganancy - lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Fosfomycin concentrations will be evaluated after completion of the study. Volunteers should collect urine samples during 7 days after administration of 3 grams fosfomycin. Afterwards, they hand in the samples and the investigators will measure the fosfomycin concentrations in the urine samples. ;Main Objective: The primary objective of this study is to measure the fosfomycin concentrations in urine after a single, oral dose of 3 grams.;Primary end point(s): fosfomycin concentrations in urine;Secondary Objective: The secondary objective of this study is to design a model which describes the pharmacokinetics and the pharmacodynamics of fosfomycin. This model will offer the possibility to predict the urine concentrations of fosfomycin and to optimise dosing regimens. Also, to find out for how long the concentrations will be 'high' and to find out which parameters (for example, age and/or renal function) influence the concentrations of fosfomycin in urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - %T>MIC will be evaluated after the fosfomycine concentrations were measured in the lab. - The renal function, based on a blood-sample, will be calculated directly after sample collection. The renal function, based on the 24-hours urine, will be calculated after the volunteers handed-in their samples. - fluid intake will be calculated after receiving this information from the volunteers.;Secondary end point(s): - Percentage of time above the minimal inhibitory concentration of the most common uropathogens (%T>MIC) - Estimation of the renal function based on creatinine in urine and in blood - Fluid intake during the sample collection week | — |
Countries
Netherlands
Contacts
Public ContactMMIZ
Erasmus MC
Outcome results
None listed