Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection

Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection - Pharmacokinetics of fosfomycin in prolonged treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46751

Enrollment

Registered

2018-12-18

Start date

2019-04-17

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

bladder infection Urinary tract infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Treatment of UTI with oral fosfomycin 3 gram every 3rd day for 14 days or longer as indicated by attending physician 2. Adults aged *18 years

Exclusion criteria

Exclusion criteria: 1. Proven allergy for fosfomycin 2. Pregnancy or breastfeeding 3. Usage of metoclopramide 4. Renal insufficiency defined as an estimated GFR

Design outcomes

Primary

Measure	Time frame
PK profile of fosfomycin, which includes: - Maximum concentration (Cmax) - Time to reach Cmax (Tmax) - Area under the curve of fosfomycin (AUC) - Elimination half-life (T¬¬¬1/2) - Bio availability	—

Secondary

Measure	Time frame
Urinary concentration of fosfomycin in 24 hours urinary sample Number of recurrent UTIs Side effects of fosfomycin	—

Countries

Netherlands

Outcome results