Fosfomycin vs Ciprofloxacin for transrectal biopsy - a randomized trial

Fosfomycin vs Ciprofloxacin for transrectal biopsy - a randomized controlled phaze II multicentre clinical trial - DUroNorr2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000772-28-SE

Enrollment

3448

Registered

2017-03-17

Start date

2017-05-16

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Prophylaxis of bacterial infections following prostate biopsies

Interventions

Trade Name: Monuril 3 g granules for oral solution Pharmaceutical Form: Granules for oral solution INN or Proposed INN: FOSFOMYCIN TROMETAMOL Current Sp

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Indication for prostate biopsy Informed consent No exclusion criteria 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 1724 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1724

Exclusion criteria

Exclusion criteria: Allergy to Fosfomycin or Ciprofloxacin Use of Tizanidine Hemodialysis or severe renal failure

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect between Fosfomycin and Ciprofloxacin when being used as antibiotic prophylaxis for prostate biopsy ; Secondary Objective: Establish the frequency of infektions in high- and low risk patients Investigate if the rectal flora is affected by Fosfomycin or ciprofloxacin Mortality Inpatient Days Risk factors ; Primary end point(s): Submission to inpatient care because of sepsis within two weeks after prostate biopsy ; Timepoint(s) of evaluation of this end point: 14 Days after the biopsy. The endpoint will be evaluated 6 months after the cancellation of the trial	—

Measure

Time frame

Main Objective: To compare the effect between Fosfomycin and Ciprofloxacin when being used as antibiotic prophylaxis for prostate biopsy ; Secondary Objective: Establish the frequency of infektions in high- and low risk patients Investigate if the rectal flora is affected by Fosfomycin or ciprofloxacin Mortality Inpatient Days Risk factors ; Primary end point(s): Submission to inpatient care because of sepsis within two weeks after prostate biopsy ; Timepoint(s) of evaluation of this end point: 14 Days after the biopsy. The endpoint will be evaluated 6 months after the cancellation of the trial

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Secondary

Measure	Time frame
Secondary end point(s): Prescribed antibiotics for UTI within 30 Days after the biopsy * Submission to hospital, same as thje primary endpoint, but exclusding patients with antibiotic resistance to Fosfomycin or Ciprofloxacin * Analysis of urine Cultures after infections following the biopsy * Inpatient care regardless of cause within 14 Days after the biopsy * Mortality <90 Days * Bacteriological carachteristics on urine cultures * Bacteriological carachtereistics on rectal swabs Before and after the biopsy (4 weeks after) * Number of inpatient Days * Daily doses of antibiotics * Risk factors for infection based on baseline data ; Timepoint(s) of evaluation of this end point: 14 Days to 90 days after the biopsy. These endpoint will be evaluated 6 months after the cancellation of the trial	—

Measure

Time frame

Secondary end point(s): Prescribed antibiotics for UTI within 30 Days after the biopsy * Submission to hospital, same as thje primary endpoint, but exclusding patients with antibiotic resistance to Fosfomycin or Ciprofloxacin * Analysis of urine Cultures after infections following the biopsy * Inpatient care regardless of cause within 14 Days after the biopsy * Mortality <90 Days * Bacteriological carachteristics on urine cultures * Bacteriological carachtereistics on rectal swabs Before and after the biopsy (4 weeks after) * Number of inpatient Days * Daily doses of antibiotics * Risk factors for infection based on baseline data ; Timepoint(s) of evaluation of this end point: 14 Days to 90 days after the biopsy. These endpoint will be evaluated 6 months after the cancellation of the trial

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Countries

Sweden

Contacts

Public ContactClinical trial information

Johan Styrke

johan.styrke@umu.se+46702992048

Outcome results

None listed

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