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Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

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ClinicalTrials.gov Identifier: NCT00480376
Recruitment Status : Unknown
Verified May 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2007
Last Update Posted : May 30, 2007
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment Phase
Infection Drug: ofloxacin Drug: gentamicin Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Study Start Date : June 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00480376     History of Changes
Other Study ID Numbers: 230105
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

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
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors