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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001344482
• Date of registration: 26/09/2016
• Prospective Registration: Yes
• Primary sponsor: University of Thessaly
• Public title: Comparing the efficacy of prulifloxacin against cefixime as a preventive treatment before transrectal ultrasound guided prostate biopsy.
• Scientific title: Evaluating the efficacy of prulifloxacin against cefixime administration before a transrectal prostate biopsy, in order to avoid severe urinary sepsis after the performance.
• Date of first enrolment: 01/11/2016
• Target sample size: 200
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001344482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Greece

Contacts

• Name: Dr Michael Samarinas

• Name: Dr Michael Samarinas

Key inclusion & exclusion criteria

Inclusion criteria: Patients eligible for prostate biopsy
Exclusion criteria: Prulifloxacin or cefixime allergy

Kidney failure,

Known resistance to prulifloxacin or cefixime

Age minimum: 40 Years
Age maximum: 75 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Renal and Urogenital - Other renal and urogenital disorders

Prostate cancer suspicious ;Urinary tract infection;
Prostate cancer suspicious
Urinary tract infection

Cancer - Prostate

Intervention(s)

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.

Primary Outcome(s)

High fever with lower urinary tract symptoms

These will be chcked by self thermometry by the patient, as well as medical history is required.[1 day after prostate biopsy]

Secondary Outcome(s)

Severe sepsis
Evaluation will be performed with:

Blood and urine examintaions and cultures.
Blood gas, respiratory frequence, blood pressure.

[3 days after prostate biopsy]

Secondary ID(s)

Nil

Source(s) of Monetary Support

University of Thessaly

Ethics review

Status: Approved
Approval date:
Contact:

Scientific Committee University Hospital of Larisa