Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Infection Clinical Trial

Official title:

Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00480376
• Other study ID #: 230105
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 29, 2007
• Last updated: May 29, 2007
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2007
• Source: HaEmek Medical Center, Israel
• Contact: Genady Zelichenko, M.D.
• Phone: 972-4-6494000
• Email: genady_ze[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients going under transrectal biopsy of prostate with sterile urine culture.

Exclusion Criteria:

• Urine culture not sterile

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• ofloxacin

• gentamicin

Locations

Country	Name	City	State
Israel	Urology outpatient clinic, HaEmek MC	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no infection		48 hours
Secondary	no infection		7 days