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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. CIRCUP 2

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519166-48-01
Acronym
CHUBX 2023/52
Enrollment
163
Registered
2025-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Urethral Valves

Brief summary

Time to first fUTI between baseline and 2 years. The diagnosis of fUTI is defined as fever (>38.5° Celsius) with evidence of pyuria and culture-proven infection on urinalysis, obtained by urethral catheterization or suprapubic aspiration, as well as biological signs of inflammation.

Detailed description

Median number of fUTIs at 2 years in children with at least 1 fUTI during follow-up, The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects) between baseline and 2-years between children with and without fUTIs, The types of germs responsible for fUTIs, Baseline risk factors for fUTIs from regression models (exploratory), Exploratory sub-group analyses in children with and without urinary reflux at baseline, Adherence to antibiotic prophylaxis in the control group, Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis;and antibiotic prophylaxis alone respectively.

Interventions

DRUGBactrim 40 mg/ml + 8 mg/ml mikstur
DRUGALFATIL 125 mg/5 ml poudre pour suspension buvable
DRUG50 mg par ml NOURRISSONS

Sponsors

Centre Hospitalier Universitaire De Bordeaux
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Time to first fUTI between baseline and 2 years. The diagnosis of fUTI is defined as fever (>38.5° Celsius) with evidence of pyuria and culture-proven infection on urinalysis, obtained by urethral catheterization or suprapubic aspiration, as well as biological signs of inflammation.

Secondary

MeasureTime frame
Median number of fUTIs at 2 years in children with at least 1 fUTI during follow-up, The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects) between baseline and 2-years between children with and without fUTIs, The types of germs responsible for fUTIs, Baseline risk factors for fUTIs from regression models (exploratory), Exploratory sub-group analyses in children with and without urinary reflux at baseline, Adherence to antibiotic prophylaxis in the control group, Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis;and antibiotic prophylaxis alone respectively.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026