Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 29, 2007 | ||||
| Last Updated Date | May 29, 2007 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
no infection [ Time Frame: 48 hours ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
no infection [ Time Frame: 7 days ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate | ||||
| Official Title ICMJE | Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Infection | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | March 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00480376 | ||||
| Other Study ID Numbers ICMJE | 230105 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | HaEmek Medical Center, Israel | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | HaEmek Medical Center, Israel | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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