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

Pilot study: Fosfomycin levels in prostate tissue after oral and iv administration - PROSAB-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44736

Enrollment

Registered

2015-11-20

Start date

2016-05-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate infection prostatitis

Interventions

administration of 2 grams iv fosfomycin at the start of the procedure, or 3 grams orally 2 ours prior to surgery

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: suspicion of or proven malignancy of the prostate known allergy to fosfomycine renal insufficiency (eGFR

Design outcomes

Primary

Measure	Time frame
To investigate prostate tissue concentrations of fosfomycin in relation to the MIC of 32 mg/g after a single iv or oral dose	—

Secondary

Measure	Time frame
To determine the relation between plasma and tissue concentrations of fosfomycin To determine plasma and intraprostatic concentration over time.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)