An evaluation of the effectivity of the current treatment of uncomplicated urinary tract infections with fosfomycin.

Completed

• Conditions: uncomplicated urinary tract infection; 10004018; 10046590

• Registration Number: NL-OMON43467
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

* Subject is female
* Age (* 18 years)
* Subject is healthy
* Written informed consent

Exclusion Criteria

* Menstruation during the urine sampling week
* Known severe renal impairment (defined as estimated glomerular [eGFR] < 30 mL/min)
* Co-medication with any antimicrobial agent within 1 month prior or with metoclopramide
* A history of intolerance/allergy to fosfomycin
* Pregnancy and/or lactation
* Male

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The concentrations in urine of fosfomycin will be assessed after a single, oral<br /><br>dose of 3 grams. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, the effectivity of this standard treatment will be evaluated based<br /><br>on the MIC of the most common uropathogens and the PK/PD target (%T>MIC) of<br /><br>fosfomycin. The influence of several parameters (i.a. renal function and urine<br /><br>production) on the distribution of these concentrations will be investigated.<br /><br>Therefore, blood samples will be taken to measure the renal function. </p><br>