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NCT01659866 · ClinicalTrials.gov registry record · Phase 4
Antibiotic Prophylaxis for Transrectal Prostate Biopsy
A Phase 4 study of Infection, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 563
- Enrollment target
- 1
- Study location
NCT01659866: Completed Phase 4 study of Infection, sponsored by Northwestern University.
NCT01659866 is a Phase 4 study of Infection that has completed, run by Northwestern University. The registered enrollment target is 563 participants, below the 713-participant average among 41 other Infection trials with a reported enrollment target (21% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659866, a Phase 4 study of Infection, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 563 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection.
Conditions Studied
Interventions
- DRUG Ciprofloxacin
- DRUG trimethoprim-sulfamethoxazole
- DRUG cefuroxime
- DRUG ceftriaxone
- DRUG gentamicin
Study Locations (1)
Illinois
- Northwestern University Department of Urology - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT01659866 record still lists
NCT01659866 is an interventional study that assigns participants to a tested intervention. The registered 563 participants enrollment target is mid-sized for trials with a published cap, below the 713-participant average among 41 other Infection trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT01659866 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01659866 about?
NCT01659866 is a clinical study titled "Antibiotic Prophylaxis for Transrectal Prostate Biopsy". 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...
What is the current status of trial NCT01659866?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 563 participants. The study started on 2012-08. Estimated completion is 2016-08.
What conditions does trial NCT01659866 study?
This clinical trial studies the following conditions: Infection.
What interventions are being tested in trial NCT01659866?
The interventions under investigation include: Ciprofloxacin (DRUG), trimethoprim-sulfamethoxazole (DRUG), cefuroxime (DRUG), ceftriaxone (DRUG), gentamicin (DRUG).
Who is sponsoring clinical trial NCT01659866?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659866 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01659866's enrollment target sits among peer trials
563 8th of 41 higher than 34 of 41 other Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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