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Trial · NCT01659866

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

NCT01659866, Phase 4, Completed, Northwestern University; results first posted 2019-06-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Antibiotic Prophylaxis for Transrectal Prostate Biopsy. Trials, record NCT01659866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01659866

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Antibiotic Prophylaxis for Transrectal Prostate Biopsy
NCT number
NCT01659866
Status
Completed
Phases
Phase 4
Enrollment
563 participants, actual
Lead sponsor
Northwestern University
Conditions
Infection
Interventions
Ciprofloxacin, trimethoprim-sulfamethoxazole, cefuroxime, ceftriaxone, gentamicin, amikacin, aztreonam, imipenem, ceftriaxone, gentamicin, amikacin, aztreonam, imipenem
First posted
2012-08-08
Last updated
2019-06-25
Results first posted
2019-06-25
Limitations and caveats
Did not reach recruiting targets due to fewer prostate biopsies being performed than originally estimated in the study period.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Post-biopsy Infection.30 days post-biopsyTo 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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Post-biopsy Infection.30 days post-biopsy
Of the 563 patients who signed consent, 53 were excluded; thus, 510 patients participated in the study. Of these 510, 430 harbored ciprofloxacin-susceptible flora and 80 harbored ciprofloxacin-resistant flora.
participantsNUMBER

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With Post-biopsy Infection.Cipro-susceptible6participants
Number of Participants With Post-biopsy Infection.Cipro-resistant3participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCipro-susceptible430
Overall StudySTARTEDCipro-resistant80
Overall StudyCOMPLETEDCipro-susceptible430
Overall StudyCOMPLETEDCipro-resistant80
Overall StudyNOT COMPLETEDCipro-susceptible0
Overall StudyNOT COMPLETEDCipro-resistant0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCipro-susceptible0430
Total, all-cause mortalityCipro-resistant080
Total, other adverse eventsCipro-susceptible0430
Total, other adverse eventsCipro-resistant080
Total, serious adverse eventsCipro-susceptible0430
Total, serious adverse eventsCipro-resistant080

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
28592230DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Cipro-susceptible vs Cipro-resistant: Number of Participants With Post-biopsy Infection.Trial comparisons
Cipro-susceptible vs Cipro-resistant: deaths from any causeTrial comparisons
Cipro-susceptible vs Cipro-resistant: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01659866

GET https://conductscience.org/api/trials/v1/NCT01659866/registered