Comparison of different antibiotics in patients undergoing prostate biopsy
| ISRCTN | ISRCTN17514039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17514039 |
| Secondary identifying numbers | 012020 |
- Submission date
- 24/08/2023
- Registration date
- 26/08/2023
- Last edited
- 15/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
In this research project, we're looking at a specific medical procedure called transrectal prostate biopsy (PB), which involves taking samples from the prostate gland to check for potential issues. Our main goal is to figure out how different short-term preventive antibiotics used during this procedure affect the chances of getting infections, considering the conditions in our local medical setup. This is connected to a concern about the safety of a type of antibiotics called fluoroquinolones that are commonly used for this purpose. Since these antibiotics might have some risky side effects, we want to find out if there are better ways to prevent infections after the biopsy. By studying this carefully, we hope to learn which approach works best and is safest for patients undergoing this procedure, and this could help doctors make better decisions for their patients.
Who can participate?
Patients who will undergo transrectal ultrasound-guided PB will be included in the study.
What does the study involve?
In this study, we're going to divide the patients into three groups randomly, based on the way they'll take antibiotics before a prostate biopsy. About 1 to 2 weeks before the biopsy, we'll gently swipe the inside of their rectum to see if any harmful bacteria are there. After the biopsy, we'll keep an eye on them for a month to see if any problems or complications come up. We want to see which antibiotic method works better at preventing issues, and we're also checking the bacteria in the rectum to understand more about what might cause infections.
What are the possible benefits and risks of participating?
The benefit is in a short-term regimen of antibiotic prophylaxis with potential minimization of side effects. The risk is the possible occurrence of infectious complications requiring further treatment or hospitalization.
Where is the study run from?
University Hospital Brno (Czech Republic)
When is the study starting and how long is it expected to run for?
November 2020 to January 2023
Who is funding the study?
The work is supported by Ministry of Health, Czech Republic - conceptual development of research organization (FNBr, 65269705).
Who is the main contact?
Ass. prof. Michal Fedorko, fedorko.michal@fnbrno.cz
krsakova.eva@fnbrno.cz
Contact information
Scientific
Department of Urology
University Hospital Brno
Jihlavská 20
Brno
62500
Czech Republic
 ORCID ID |
0000-0001-6893-8829 |
|---|---|
| Fedorko.Michal@fnbrno.cz |
Scientific
Department of Urology
University Hospital Brno
Jihlavská 20
Brno
62500
Czech Republic
| Phone | +42 1911976853 |
|---|---|
| krsakova.eva@fnbrno.cz |
Study information
| Study design | Single-center interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Comparison of efficacy of three different regimens of Short-term ANtibiotic prophylaxis in TRransrectal prostate bIOpsy |
| Study acronym | SANTRIO |
| Study hypothesis | Short-term fosfomycin trometamol is an effective alternative to ciprofloxacin-based regimens. |
| Ethics approval(s) |
Approved 04/11/2020, Ethics Committee of University Hospital Brno (Jihlavská 20, Brno, 62500, Czech Republic; +42 0532232805; rosenbaumova.lenka@fnbrno.cz), ref: 05-041120/EK |
| Condition | Prevention of infectious complications in patients undergiong transrectal prostate biopsy |
| Intervention | Patients who will undergo transrectal prostate biopsy will be randomized according to the regimen of antibiotic prophylaxis into 3 groups: 1. Fosfomycin trometanol 3g before the procedure + ciprofloxacin 500mg 2 hours before the procedure 2. Fosfomycin trometamol 3g before and 24 hours after the procedure 3. Ciprofloxacin 500mg 12 hours abd 2 hours before the procedure and 12 hours after the procedure. Follow-up of study arms 4-6 weeks Randomization based on the month of study based on the application for ordering patients for procedures. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fosfomycin trometamol, ciprofloxacin |
| Primary outcome measure | The occurrence of infectious complications during the follow-up period will be assessed during a personal follow-up visit within 4-6 weeks after the procedure. In case of symptoms of infectious complications, these will be recorded at any time during the follow-up period |
| Secondary outcome measures | Evidence of adverse events of short-term antibiotic prophylaxis during the follow-up period will be assessed during a personal follow-up visit within 4-6 weeks after the procedure |
| Overall study start date | 04/11/2020 |
| Overall study end date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 99 Years |
| Sex | Male |
| Target number of participants | 600 |
| Total final enrolment | 550 |
| Participant inclusion criteria | Patients indicated for transrectal prostate biopsy based on PSA and/or PHI level, digital rectal examination finding of magnetic resonance finding. |
| Participant exclusion criteria | Allergy to any of the antibiotic or local anesthetic, indwelling urinary catheter or epicystostomy, patients requiring other antibiotic prophylaxis due to other medical condition. |
| Recruitment start date | 01/01/2021 |
| Recruitment end date | 31/12/2022 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Brno
62500
Czech Republic
Sponsor information
Hospital/treatment centre
Jihlavska 20
Brno
62500
Czech Republic
| Phone | +420532233860 |
|---|---|
| fnbrno@fnbrno.cz | |
| Website | http://www.fnbrno.cz/en/ |
"ROR" |
https://ror.org/00qq1fp34 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a high-impact peer-reviewed journal. Presentation of the results at national scientific meetings. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Michal Fedorko (fedorko.michal@fnbrno.cz). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/01/2024 | 15/01/2024 | Yes | No |
Editorial Notes
15/01/2024: Publication reference added.
13/12/2024: The intention to publish date was changed from 01/12/2023 to 01/03/2024.
25/08/2023: Trial's existence confirmed by Ethics Committee of University Hospital Brno.
