drugset / Trial / NCT01659866

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

NCT01659866

Phase 4 Completed 563 enrolled Northwestern University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is being conducted in men scheduled to undergo transrectal ultrasound-guided prostate biopsy (TRUSP). Traditionally prior to prostate biopsy, an antibiotic, ciprofloxacin, has been given to men to prevent biopsy-related infections. In recent years as ciprofloxacin resistance has increased in the community, more and more men are becoming infected with ciprofloxacin-resistant bacteria after prostate biopsy. This study is being done to determine if obtaining rectal swab cultures and choosing antibiotics based on these culture results will result in fewer infectious complications than giving all men ciprofloxacin. The investigators will compare 2 groups: men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy, and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative antibiotics based on their culture results. Our hypothesis is that these 2 groups will have equal numbers of post-biopsy infectious complications and both groups will have fewer infectious complications than a historical group who received empiric ciprofloxacin without the benefit of rectal swab culture results.

Timeline

Start
2012-08
Primary completion
2015-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amikacin Small molecule 5 mg/kg Intramuscular
Comparator Aztreonam Small molecule 500 mg Intramuscular
Comparator Aztreonam Small molecule 2000 mg Intramuscular
Comparator Ceftriaxone Other / unclassified 500 mg Intramuscular
Comparator Ceftriaxone Other / unclassified 2000 mg Intramuscular
Comparator Cefuroxime Small molecule 500 mg Oral
Subject Ciprofloxacin Small molecule 500 mg Oral
Comparator Gentamicin Small molecule 2 mg/kg Intramuscular
Comparator IMIPENEM ANHYDROUS Small molecule 500 mg Intramuscular
Comparator IMIPENEM ANHYDROUS Small molecule 1000 mg Intramuscular
Comparator trimethoprim-sulfamethoxazole Unknown Oral

Indications