Could circumcision replace antibiotics for preventing kidney infections in newborns with PUV?
NCT ID NCT07527442
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at newborn boys with posterior urethral valves (PUV), a rare birth defect that raises the risk of serious kidney infections. It compares circumcision alone versus circumcision plus daily antibiotics to see if the surgery alone is enough to prevent these infections. About 72 boys will be followed for two years to track infection rates and kidney health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 31 days
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\- Inclusion Criteria: For prospective groups: Male child aged 1 to 31 days Posterior urethral valves diagnosed by cystography within the first 28 days of life Valve resection and circumcision performed before 1 month of life. Adult guardians (\>18 years) Parental guardians affiliated with a social security system Parental guardians who have signed an informed consent allowing their child to participate in the study Parental guardians giving consent must be able to understand the trial in its entirety For retrospective groups from CIRCUP : Parental guardians who are not opposed to their child's participation in the trial \- Exclusion Criteria: 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) Long-term antibiotics use indicated for other reasons than PUV
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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APHM
Marseille, France
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APHP Hôpital Armand Trousseau
Paris, 75012, France
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APHP Hôpital Necker
Paris, 75015, France
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APHP Hôpital Robert Debré
Paris, 75019, France
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CHU de Besançon
Besançon, France
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CHU de Bordeaux
Bordeaux, France
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CHU de Limoges
Limoges, France
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CHU de Montpellier
Montpellier, France
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CHU de Nantes
Nantes, France
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CHU de Reims
Reims, France
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CHU de Rennes
Rennes, France
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CHU de Toulouse
Toulouse, France
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CHU de la Réunion
Saint-Denis, 97400, France
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