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| Sponsor: | HaEmek Medical Center, Israel |
|---|---|
| Information provided by: | HaEmek Medical Center, Israel |
| ClinicalTrials.gov Identifier: | NCT00480376 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate |
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | March 2008 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Genady Zelichenko, M.D. | 972-4-6494000 ext 306 | genady_ze@clalit.org.il |
| Israel | |
| Urology outpatient clinic, HaEmek MC | |
| Afula, Israel, 18101 | |
| Principal Investigator: | Genady Zelychenko, MD | Ha'Emek Medical Center, Afula, Israel |
More Information
| Study ID Numbers: | 230105 |
| Study First Received: | May 29, 2007 |
| Last Updated: | May 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00480376 History of Changes |
| Health Authority: | Israel: Ethics Commission |
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transrectal biopsy prostate prophylaxis antibiotic |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Ofloxacin Enzyme Inhibitors Anti-Infective Agents, Urinary Infection Renal Agents |
Pharmacologic Actions Anti-Bacterial Agents Protein Synthesis Inhibitors Therapeutic Uses Gentamicins Nucleic Acid Synthesis Inhibitors |