EUCTR2018-000616-25-NL
Active, not recruiting
Phase 1
Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection
Not provided0 sites15 target enrollmentJanuary 21, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Not provided
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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