Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Recruitment status was Not yet recruiting
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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 |
- no infection [ Time Frame: 48 hours ]
- no infection [ Time Frame: 7 days ]
| 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:
- Patients going under transrectal biopsy of prostate with sterile urine culture.
Exclusion Criteria:
- Urine culture not sterile
Contacts and Locations| Contact: Genady Zelichenko, M.D. | 972-4-6494000 ext 306 | genady_ze@clalit.org.il |
| 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 | |
| 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 Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 17, 2013