Ciprofloxacin vs Trimetoprim/Sulfametoxazol for prostate biopsy - a clinical trial

Phase 1

• Conditions: Prophylaxis of bacterial infektions of the prostate following transrectal prostate biopsy; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002999-83-SE
• Lead Sponsor: Johan Styrke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 2550

Inclusion Criteria

Indication for prostate biopsy
Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1275

Exclusion Criteria

•Diabetes Mellitus
•Kateter à demeure
•Urinary tract infection (past 6 months)
•Positive nitritis on urinary dipstick
•Allergy for Ciprofloxacin, Trimetoprim/Sulfametoxazol or other agents in the IMP
•Liver damage
•Use of Tizanidine
•Immunosuppression

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigage if Trimetoprim/Sulfametoxazol is non inferior campared to Ciprofloxacin as antibiotic prophylaxis for transrectal prostate biopsy;Secondary Objective: To asses after prostate biopsy:<br>1, Mortality<br>2, Bacteriological carachteristisc<br>3, Time to desease<br>4, Number of inpatient days<br>5, The given number of doses of antibiotics if infection occurrs.<br>6, Riskfactors for infection.;Primary end point(s): •Subscribed urinary tract antibiotics within 2 weeks following prostate biopsy<br>•Submission to inpatient hospital care within 2 weeks after prostate biopsy for urinary tract infektion or sepsis.;Timepoint(s) of evaluation of this end point: 2 weeks after prostete biopsy. The first primary endpoint will be avaluated in an interim analysis every 6 months of the trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Mortalitet (3 mån efter biopsi)<br>•Bakteriologisk karaktäristika på fallens blod- respektive urinodlingar.<br>•Tid till sjukdomsdebut.<br>•Vårdtid på sjukhus.<br>•Antal dygnsdoser antibiotika.<br>•Den exkluderade riskgruppens infektionsfrekvens.<br>•Riskgruppens inbördes riskstratifiering.<br>•Riskfaktorer för infektion, analys av baslinjevariabler.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated after the trial is closed for inclusion, approximately 2-3 years after the start of the trial.