Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Prostate biopsy is usually conducted as an ambulatory transrectal needle aspiration, ultrasonography guided. The area is not sterile, with high concentration of gram-negative and anaerobic pathogens, infection can be induced during the procedure to the urinary tract, and even cause bacteremia.

Prior studies concluded that prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections and hence it is accepted to give prophylaxis antibiotics which will cover especially gram-negative bacteria. Other studies show decrease in infections percent in patients that received prophylaxis opposed to those who did not, from 5-30% to less than 1%. Yet, there was no significant difference between those who received one dose and those who were treated for 3-5 days. Quinolones are considered preferred treatment since they can be given orally, 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.

Conditions

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Infection

Keywords

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transrectal biopsy prostate prophylaxis antibiotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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ofloxacin

Intervention Type DRUG

gentamicin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Urine culture not sterile

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Genady Zelychenko, MD

Role: PRINCIPAL_INVESTIGATOR

Ha'Emek Medical Center, Afula, Israel

Locations

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Urology outpatient clinic, HaEmek MC

Afula, , Israel

Site Status

Countries

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Israel

Central Contacts

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Genady Zelichenko, M.D.

Role: CONTACT

Phone: 972-4-6494000

Email: [email protected]

Facility Contacts

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Genady Zelichenko, MD

Role: primary

Other Identifiers

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230105

Identifier Type: -

Identifier Source: org_study_id