drugset / Trial / NCT02423759

A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy

NCT02423759

Phase 4 Completed 510 enrolled Mansoura University
RandomizedParallel-groupSingle-blindPrevention

Summary

The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.

Timeline

Start
2015-04
Primary completion
2017-01-16
Completion
2017-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 500 mg
Subject Gentamicin Small molecule 160 mg Intramuscular