Urinary tract infection
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients having been prescribed nitrofurantoin by treating physician because suspicion of or proven urinary tract infection. 2. Age of at least 18 years. 3. Female sex 4. Glomerular filtration rate (GFR) greater than or equal to 30 ml/min based on creatinine clearance. 5. Written informed consent by patient or legal representative
Exclusion criteria
Exclusion criteria: 1. Treated with any antibiotics within 1 week of potential sampling period. 2. Known porphyria 3. Known allergic reaction or anaphylactic shock as a result of the consumption of nitrofurantoin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the NF concentrations in urine. Nitrofurantoin urine levels will be analysed by means of a validated ultra high-performance liquid chromatography with UV detection (UPLC-UV) at the UMC of Maastricht. Pharmacokinetic analysis A classic pharmacokinetic curve will be developed through analysis of the pharmacokinetic data. Afterwards, a population PK analysis will be performed. Other covariates, such as age, weight, and creatinine clearance will be included in the analysis. Through this approach both intra- and inter-individual variability will be taken into account. The computer program NONMEM (nonlinear mixed effects modelling) will be used for this purpose, which is acknowledge by e.g. the FDA for this purpose. Results will be analyzed and the model will be validated according to internationally recommended standards. With this programm, we can simulate different dosing regimen in order to find the most optimal regimen so that treatment with nitrofurantoin will be optimized regarding its effectivity and safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed