Pilot study: Fosfomycin levels in prostate tissue after oral and iv administratio

Phase 2

Completed

• Conditions: prostate infection; prostatitis; 10004018

• Registration Number: NL-OMON44736
• Lead Sponsor: HagaZiekenhuis

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: 30

Inclusion Criteria

a planned transurethral resection of the prostate in patiënts with complaints caused by benign prostatic hyperplasia (BPH)

Exclusion Criteria

suspicion of or proven malignancy of the prostate
known allergy to fosfomycine
renal insufficiency (eGFR < 40 ml/min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate prostate tissue concentrations of fosfomycin in relation to the<br /><br>MIC of 32 mg/g after a single iv or oral dose</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the relation between plasma and tissue concentrations of fosfomycin<br /><br>To determine plasma and intraprostatic concentration over time.</p><br>