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PROSTABACT : Relevance of the treatment with antibiotics before endoscopic surgery of lower urinary symptoms related to prostate hypertrophy with polymicrobial bacterial culture performed before the surgery: a non-inferiority randomized trial
EU CTIS ID: 2023-510191-31-00
What this study is testing
To demonstrate that not treating a patient with a polymicrobial UBC performed before BPH surgery is not inferior to treating him with antibiotic in terms of urinary tract infection incidence over a one-month post-surgery period.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult men ≥ 18 years of age
- Person affiliated to a French social security system or equivalent
- Written informed consent obtained from the participant
- Scheduled to have a surgery of lower urinary Tract Symptoms (LUTS) due to BPH, (Urolift, rezum, aquabeam, monopolar or bipolar Trans-uretral resection of the prostate, enucleation of the prostate (Holep, Greenlep, bipolep), simple prostatectomy)
- With polymicrobial pre-operative urine culture (three or more pathogens identified).
- Able to comply with the requirements of the study
You likely can't join if
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: persons deprived of their liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or trusteeship)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Patients already treated by antibiotic for non-urological situations
- Concomitant participation in other pharmacological study
- Patients in medical emergency
- Mental state making the patient unable to understand this research
See the full eligibility criteria
- Adult men ≥ 18 years of age
- Person affiliated to a French social security system or equivalent
- Written informed consent obtained from the participant
- Scheduled to have a surgery of lower urinary Tract Symptoms (LUTS) due to BPH, (Urolift, rezum, aquabeam, monopolar or bipolar Trans-uretral resection of the prostate, enucleation of the prostate (Holep, Greenlep, bipolep), simple prostatectomy)
- With polymicrobial pre-operative urine culture (three or more pathogens identified).
- Able to comply with the requirements of the study
- Patients able to understand this clinical research
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: persons deprived of their liberty by judicial or administrative decision and persons subject to a legal protection measure: guardianship or trusteeship)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)
- Patients already treated by antibiotic for non-urological situations
- Concomitant participation in other pharmacological study
- Patients in medical emergency
- Mental state making the patient unable to understand this research
- Patient being the investigator as well as any member of the team or close relative of the investigator directly involved in the trial, in particular assistant doctors, pharmacists, nurses, trial coordinator
- Contraindications to antibiotic drugs administered in this study
- Infection within 6 months before surgery
- Hospitalisation within 6 months before surgery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.