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.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001344482

Enrollment

200

Registered

2016-09-26

Start date

2016-11-01

Completion date

2018-10-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients eligible for prostate biopsy

Exclusion criteria

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

Outcome results