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

Phase 2

Completed

• Conditions: bladder infection; Urinary tract infection; 10004018; 10046590

• Registration Number: NL-OMON46751
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-01
• Results First Posted: 2020-07-26
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

1. Proven allergy for fosfomycin
2. Pregnancy or breastfeeding
3. Usage of metoclopramide
4. Renal insufficiency defined as an estimated GFR <30 ml/minute calculated by MDRD method
5. Active malignancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK profile of fosfomycin, which includes:<br /><br>- Maximum concentration (Cmax)<br /><br>- Time to reach Cmax (Tmax)<br /><br>- Area under the curve of fosfomycin (AUC)<br /><br>- Elimination half-life (T¬¬¬1/2)<br /><br>- Bio availability </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Urinary concentration of fosfomycin in 24 hours urinary sample<br /><br>Number of recurrent UTIs<br /><br>Side effects of fosfomycin</p><br>