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Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00480376
Enrollment
160
Registered
2007-05-30
Start date
2007-06-30
Completion date
2008-03-31
Last updated
2007-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

transrectal biopsy, prostate, prophylaxis antibiotic

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.

Detailed description

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.

Interventions

DRUGgentamicin

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Urine culture not sterile

Design outcomes

Primary

MeasureTime frame
no infection48 hours

Secondary

MeasureTime frame
no infection7 days

Countries

Israel

Contacts

Primary ContactGenady Zelichenko, M.D.
genady_ze@clalit.org.il972-4-6494000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026