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Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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; Not yet recruiting
Genady Zelichenko, MD, Phone: 972-4-6494000, Ext: 306, Email: genady_ze@clalit.org.il
Genady Zelichenko, MD, Principal Investigator
Additional Information

Starting date: June 2007
Last updated: May 29, 2007

Page last updated: August 23, 2015

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