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Pharmacokinetics of nitrofurantoin

Pharmacokinetics of nitrofurantoin in the elderly

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-004174-10-NL
Enrollment
Unknown
Registered
2013-10-23
Start date
2013-11-18
Completion date
Unknown
Last updated
2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated urinary tract infection

Interventions

Trade Name: Nitrofurantoin Product Name: Nitrofurantoin Pharmaceutical Form: Capsule INN or Proposed INN: Nitrofurantoin CAS Number: 67-20-9 Other descriptive name: NITROFURANTOIN Concentration unit:

Sponsors

UMC St Radboud
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients having been prescribed nitrofurantoin by treating physician because suspicion of or proven urinary tract infection. - Age > 55 and =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Treated with any antibiotics within 1 week of potential sampling period. - Known porphyria - Known allergic reaction or anaphylactic shock as a result of the consumption of nitrofurantoin

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the pharmacokinetics of orally administered nitrofurantoin in older hospitalised female patients with suspected or proven, active urinary tract infection. ;Secondary Objective: Not applicable;Primary end point(s): Nitrofurantoin plasma and urine levels.;Timepoint(s) of evaluation of this end point: At the analysis of all concentrations of nitrofurantoin in serum and urine.

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Countries

Netherlands

Contacts

Public Contactcoordinating investigator

St Elisabeth hospital

e.verhaegh@elisabeth.nl00310135392650

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026