Fosfomycin vs Ciprofloxacin for transrectal biopsy - a randomized trial
Phase 1
- Conditions
- Prophylaxis of bacterial infections following prostate biopsiesTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000772-28-SE
- Lead Sponsor
- Johan Styrke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3448
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
Allergy to Fosfomycin or Ciprofloxacin
Use of Tizanidine
Hemodialysis or severe renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To compare the effect between Fosfomycin and Ciprofloxacin when being<br> used as antibiotic prophylaxis for prostate biopsy<br> ;<br> Secondary Objective: Establish the frequency of infektions in high- and low risk patients<br> Investigate if the rectal flora is affected by Fosfomycin or ciprofloxacin<br> Mortality<br> Inpatient Days<br> Risk factors<br> ;<br> Primary end point(s): Submission to inpatient care because of sepsis within two weeks after<br> prostate biopsy<br> ;<br> Timepoint(s) of evaluation of this end point: 14 Days after the biopsy. The endpoint will be evaluated 6 months after<br> the cancellation of the trial<br>
- Secondary Outcome Measures
Name Time Method