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

Ciprofloxacin vs Trimetoprim/Sulfametoxazol for transrectal prostate biopsy - a randomized double blind phaze IV multicentre clinical trial - DURONORR 1

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002999-83-SE

Enrollment

2550

Registered

2014-12-03

Start date

2015-01-21

Completion date

Unknown

Last updated

2022-08-22

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

Conditions

Prophylaxis of bacterial infektions of the prostate following transrectal prostate biopsy

Interventions

Trade Name: Bactrim Forte Pharmaceutical Form:

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 1, Mortality 2, Bacteriological carachteristisc 3, Time to desease 4, Number of inpatient days 5, The given number of doses of antibiotics if infection occurrs. 6, Riskfactors for infection.;Primary end point(s): • Subscribed urinary tract antibiotics within 2 weeks following prostate biopsy • 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.	—

Measure

Time frame

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: 1, Mortality 2, Bacteriological carachteristisc 3, Time to desease 4, Number of inpatient days 5, The given number of doses of antibiotics if infection occurrs. 6, Riskfactors for infection.;Primary end point(s): • Subscribed urinary tract antibiotics within 2 weeks following prostate biopsy • 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.

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Secondary

Measure	Time frame
Secondary end point(s): • Mortalitet (3 mån efter biopsi) • Bakteriologisk karaktäristika på fallens blod- respektive urinodlingar. • Tid till sjukdomsdebut. • Vårdtid på sjukhus. • Antal dygnsdoser antibiotika. • Den exkluderade riskgruppens infektionsfrekvens. • Riskgruppens inbördes riskstratifiering. • 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.	—

Measure

Time frame

Secondary end point(s): • Mortalitet (3 mån efter biopsi) • Bakteriologisk karaktäristika på fallens blod- respektive urinodlingar. • Tid till sjukdomsdebut. • Vårdtid på sjukhus. • Antal dygnsdoser antibiotika. • Den exkluderade riskgruppens infektionsfrekvens. • Riskgruppens inbördes riskstratifiering. • 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.

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Countries

Sweden

Contacts

Public ContactClinical trial information

Johan Styrke

johan.styrke@umu.se+46060181000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026