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
  Purpose

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.


Condition Intervention Phase
Infection
Drug: ofloxacin
Drug: gentamicin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • no infection [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • no infection [ Time Frame: 7 days ]

Estimated Enrollment: 160
Study Start Date: June 2007
Estimated Study Completion Date: March 2008
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Urine culture not sterile
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480376

Contacts
Contact: Genady Zelichenko, M.D. 972-4-6494000 ext 306 genady_ze@clalit.org.il

Locations
Israel
Urology outpatient clinic, HaEmek MC Not yet recruiting
Afula, Israel, 18101
Contact: Genady Zelichenko, MD    972-4-6494000 ext 306    genady_ze@clalit.org.il   
Principal Investigator: Genady Zelichenko, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Genady Zelychenko, MD Ha'Emek Medical Center, Afula, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480376     History of Changes
Other Study ID Numbers: 230105
Study First Received: May 29, 2007
Last Updated: May 29, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
transrectal biopsy
prostate
prophylaxis antibiotic

Additional relevant MeSH terms:
Gentamicins
Ofloxacin
Levofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014