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Efficacy and safety of circumcision alone on risk of febrile urinary tract infections in boys with posterior urethral valves: a prospective randomized open-label multicentric trial enriched with historic controls
EU CTIS ID: 2024-519166-48-01
What this study is testing
To assess the effect of circumcision alone on risk of fUTIs at 2-years, in children with PUV, as well as the effect of the combination of circumcision and antibiotic prophylaxis; and of antibiotic prophylaxis alone by enrichment with historic controls.
- Therapeutic exploratory (Phase II)
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
- For prospective groups: Male child aged 1 to 31 days
- For prospective groups: Valve resection and circumcision performed before 1 month of life.
- For prospective groups: Adult guardians (>18 years)
- For prospective groups: Posterior urethral valves diagnosed by cystography within the first 28 days of life
- For prospective groups: Parental guardians affiliated with a social security system
- For prospective groups: Parental guardians who have signed an informed consent allowing their child to participate in the study
You likely can't join if
- Long-term antibiotics use indicated for other reasons than PUV
- Mental state rendering the person giving consent incapable of understanding the trial
- Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
- Known contra-indication to all antibiotics used in the study (Alfatil®, Bactrim®, Augmentin®)
See the full eligibility criteria
- For prospective groups: Male child aged 1 to 31 days
- For prospective groups: Valve resection and circumcision performed before 1 month of life.
- For prospective groups: Adult guardians (>18 years)
- For prospective groups: Posterior urethral valves diagnosed by cystography within the first 28 days of life
- For prospective groups: Parental guardians affiliated with a social security system
- For prospective groups: Parental guardians who have signed an informed consent allowing their child to participate in the study
- For retrospective groups from CIRCUP : Parental guardians who are not opposed to their child's participation in the trial
- For prospective groups: Parental guardians giving consent must be able to understand the trial in its entirety
- Long-term antibiotics use indicated for other reasons than PUV
- Mental state rendering the person giving consent incapable of understanding the trial
- Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
- Known contra-indication to all antibiotics used in the study (Alfatil®, Bactrim®, Augmentin®)
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, 0-17 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.