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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01659866
The ClinicalTrials.gov registry entry for NCT01659866 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 563 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 713-participant average among 41 other Infection trials with a reported enrollment target (21% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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