Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480376
Status:
UNKNOWN
Last Update Posted:
2007-05-30
First Post:
2007-05-29
Brief Title:
Ofloxacin vs Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Ofloxacin vs Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None