Fosfomycin concentrations in blood in persons with prolonged treatment with fosfomyci

Phase 1

• Conditions: Patients with recurrent urinary tract infections; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2018-000616-25-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

?Adults aged =18 years
?Treatment of UTI with oral fosfomycin 3 gram every 3rd day for 14 days or longer as indicated by attending physician
?Ability to communicate well with the investigator in the Dutch language

?Written informed consent

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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Renal insufficiency defined as an estimated GFR <30 ml/minute calculated by MDRD method
?Proven allergy for fosfomycin
?Pregnancy or breastfeeding
?Active malignancy
?Loss or donation of =500 mL of blood within 90 days prior to screening

?Participation in an investigational drug study within 90 days prior to Day 1 or more than 4 times a year

?Any known factor, condition, or disease that might interfere in the opinion of the PI with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

?Usage of metoclopramide

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pharmacokinetics of fosfomycine in patients with prolonged fosfomycin therapy to treat urinary tract infection;Secondary Objective: To assess the effect and safety of prolonged fosfomycin treatment in recurrent and/or complicated urinary tract infections. ;Primary end point(s): not applicable on this study;Timepoint(s) of evaluation of this end point: not applicable on this study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable on this study;Timepoint(s) of evaluation of this end point: not applicable on this study