drugset / Trial / NCT00480376

Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

NCT00480376

Phase 4 Unknown 160 enrolled HaEmek Medical Center, Israel
RandomizedParallel-groupOpen-labelPrevention

Summary

Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is not sterile, infection can be induced during the procedure. Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections. Quinolones are considered preferred treatment but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Timeline

Start
2007-06
Primary completion
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule
Subject Ofloxacin Small molecule

Indications