Not Yet RecruitingPhase 4ACTRN12616001344482

Comparing the efficacy of prulifloxacin against cefixime as a preventive treatment before transrectal ultrasound guided prostate biopsy.

Evaluating the efficacy of prulifloxacin against cefixime administration before a transrectal prostate biopsy, in order to avoid severe urinary sepsis after the performance.


Sponsor

University of Thessaly

Enrollment

200 participants

Start Date

Nov 1, 2016

Study Type

Interventional

Conditions

Summary

Patients eligible for prostate biopsy, either after a high PSA or a DRE finding, will receive a dose of prulifloxacin 600mg (Group 1) or cefixime 400mg (Group 2) before the performance, in order to test if lower urinary tract infection or sepsis can be prevented. They will be evaluated for urinary infection in the following 3 days, based on fever and lower urinary tract symptoms. The results will be statistically studied so as to prove any difference between the two Groups.


Eligibility

Sex: MalesMin Age: 40 YearssMax Age: 75 Yearss

Inclusion Criteria1

  • Patients eligible for prostate biopsy

Exclusion Criteria3

  • Prulifloxacin or cefixime allergy
  • Kidney failure,
  • Known resistance to prulifloxacin or cefixime

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Interventions

Patients eligible for prostate biopsy will receive either oral tablet prulifloxacin 600mg once daily for three days (Group 1) or oral tablet cefixime 400mg (Group 2) once daily for three days, as prev

Patients eligible for prostate biopsy will receive either oral tablet prulifloxacin 600mg once daily for three days (Group 1) or oral tablet cefixime 400mg (Group 2) once daily for three days, as prevention treatment before biopsy. Monitoring will be based on high fever followed with lower urinary tract symptoms up to 3 days after the performance, The adherence to the treatment will be checked, as patinets are asked to recieve each drug some hours before biopsy, inside the urology department.


Locations(1)

Thessaly, Greece

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ACTRN12616001344482