Comparison of different antibiotics in patients undergoing prostate biopsy

Comparison of efficacy of three different regimens of Short-term ANtibiotic prophylaxis in TRransrectal prostate bIOpsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17514039

Enrollment

600

Registered

2023-08-26

Start date

2021-01-01

Completion date

Unknown

Last updated

2024-01-29

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

Conditions

Prevention of infectious complications in patients undergiong transrectal prostate biopsy Infections and Infestations

Interventions

Patients who will undergo transrectal prostate biopsy will be randomized according to the regimen of antibiotic prophylaxis into 3 groups: 1. Fosfomycin trometanol 3g before the proced

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients indicated for transrectal prostate biopsy based on PSA and/or PHI level, digital rectal examination finding of magnetic resonance finding.

Exclusion criteria

Exclusion criteria: Allergy to any of the antibiotic or local anesthetic, indwelling urinary catheter or epicystostomy, patients requiring other antibiotic prophylaxis due to other medical condition.

Design outcomes

Primary

Measure	Time frame
The occurrence of infectious complications during the follow-up period will be assessed during a personal follow-up visit within 4-6 weeks after the procedure. In case of symptoms of infectious complications, these will be recorded at any time during the follow-up period	—

Secondary

Measure	Time frame
Evidence of adverse events of short-term antibiotic prophylaxis during the follow-up period will be assessed during a personal follow-up visit within 4-6 weeks after the procedure	—

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026