Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Information source: HaEmek Medical Center, Israel
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection
Intervention: ofloxacin (Drug); gentamicin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s):
Genady Zelychenko, MD, Principal Investigator, Affiliation: Ha'Emek Medical Center, Afula, Israel
Overall contact:
Genady Zelichenko, M.D., Phone: 972-4-6494000, Ext: 306, Email: genady_ze@clalit.org.il
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.
Clinical Details
Official title: Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: no infection
Secondary outcome: no infection
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Patients going under transrectal biopsy of prostate with sterile urine culture.
Exclusion Criteria:
- Urine culture not sterile
Locations and Contacts
Genady Zelichenko, M.D., Phone: 972-4-6494000, Ext: 306, Email: genady_ze@clalit.org.il
Urology outpatient clinic, HaEmek MC, Afula 18101, Israel
Additional Information
Starting date: June 2007
Ending date: March 2008
Last updated: May 29, 2007
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