NCT00480376

Brief Summary

Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is not sterile, infection can be induced during the procedure. Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections. Quinolones are considered preferred treatment but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 30, 2007

Status Verified

May 1, 2007

First QC Date

May 29, 2007

Last Update Submit

May 29, 2007

Conditions

Infection

Keywords

transrectal biopsyprostateprophylaxis antibiotic

Outcome Measures

Primary Outcomes (1)

  • no infection

    48 hours

Secondary Outcomes (1)

  • no infection

    7 days

Interventions

ofloxacinDRUG
gentamicinDRUG

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients going under transrectal biopsy of prostate with sterile urine culture.

You may not qualify if:

  • Urine culture not sterile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology outpatient clinic, HaEmek MC

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Infections

Interventions

OfloxacinGentamicins

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Genady Zelychenko, MD

    Ha'Emek Medical Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Genady Zelichenko, M.D.

CONTACT

972-4-6494000genady_ze@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

June 1, 2007

Study Completion

March 1, 2008

Last Updated

May 30, 2007

Record last verified: 2007-05

Locations

IL(1)