The primary objective of this study is to provide an updated pharmacokinetic profile of orally administered nitrofurantoin in women aged 55 to 75 years.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentration-time curve of nitrofurantoin
Secondary outcome
not applicable
Background summary
Nitrofurantoin is an antibiotic used for the treatment of lower urinary tract
infections for more than 50 years. There has been a recent resurgence of
interest in this drug in the context of increasing multidrug resistance amongst
Gram-negative bacteria causing urinary tract infections. However, given the era
of its development, there is a paucity of pharmacokinetic data for
nitrofurantoin that meet contemporary standards.
Study objective
The primary objective of this study is to provide an updated pharmacokinetic
profile of orally administered nitrofurantoin in women aged 55 to 75 years.
Study design
We propose a prospective study of nitrofurantoin*s pharmacokinetics in female
patients. This study will involve patients after their physician prescribed
nitrofurantoin for (suspected) urinary tract infection. After the start of
therapy patients will be asked informed consent. Demographic and clinical data
will be collected from patients in addition to blood and urine samples in order
to perform population pharmacokinetic modelling to produce a full
pharmacokinetic profile of nitrofurantoin in female patients with urinary tract
infection.
Study burden and risks
intravenous catheter for 6 hours and collection of urine during 24 hours
Geert grooteplein-zuid 10
Nijmegen 6525 GA
NL
Geert grooteplein-zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- use of nitrofurantoin
- female sex
Exclusion criteria
- Treated with any antibiotics within 1 week of potential sampling period
- Known allergic reaction or anaphylactic shock as a result of the consumption of nitrofurantoin
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004174-10-NL |
| CCMO | NL46061.008.13 |