Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00480376
First received: May 29, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

May 29, 2007
May 29, 2007
June 2007
Not Provided
no infection [ Time Frame: 48 hours ]
Same as current
No Changes Posted
no infection [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infection
  • Drug: ofloxacin
  • Drug: gentamicin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
March 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Urine culture not sterile
Male
21 Years and older
No
Contact: Genady Zelichenko, M.D. 972-4-6494000 ext 306 genady_ze@clalit.org.il
Israel
 
NCT00480376
230105
No
Not Provided
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Genady Zelychenko, MD Ha'Emek Medical Center, Afula, Israel
HaEmek Medical Center, Israel
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP