CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 563 enrolled
Drug / intervention
Ciprofloxacin +12 moredrug
Likely dose
Ciprofloxacin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01659866
NCT01659866Phase 4Completed

Evaluation of Directed Antimicrobial Prophylaxis for Transrectal Ultrasound Guided Prostate Biopsy (TRUSP)

Northwestern University·interventional·Posted Aug 8, 2012·Updated Jun 25, 2019

In Brief

A Phase 4 clinical trial evaluating Ciprofloxacin, trimethoprim-sulfamethoxazole, and 6 other interventions for Infection. Completed, enrolled 563 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2012
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2015
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.9 years ago

Interventions

Ciprofloxacindrug

500 mg orally 2 hours before prostate biopsy

trimethoprim-sulfamethoxazoledrug

1 double strength tablet orally 2 hours before the procedure and again 12 hours later

cefuroximedrug

500 mg orally 2 hours before the procedure then again 12 hours later

ceftriaxonedrug

500 mg intramuscularly 2 hours before the procedure

gentamicindrug

2 mg/kg intramuscularly 2 hours before the procedure

amikacindrug

5 mg/kg intramuscularly 2 hours before the procedure

aztreonamdrug

500 mg intramuscularly 2 hours before the procedure

imipenemdrug

500 mg intramuscularly 2 hours before the procedure

ceftriaxonedrug

2000 mg intravenously 1 hour before the procedure

gentamicindrug

2 mg/kg intravenously 1 hour before the procedure

amikacindrug

5 mg/kg intravenously 1 hour before the procedure

aztreonamdrug

2000 mg intravenously 1 hour before the procedure

imipenemdrug

1000 mg intravenously 1 hour before the procedure