Amoxicillin; Clavulanic acid for Posterior urethral valves

Inclusion criteria

• {"criterion_text":"- For prospective groups: Male child aged 1 to 31 days"}
• {"criterion_text":"- For prospective groups: Valve resection and circumcision performed before 1 month of life."}
• {"criterion_text":"- For prospective groups: Adult guardians (>18 years)"}
• {"criterion_text":"- For prospective groups: Posterior urethral valves diagnosed by cystography within the first 28 days of life"}
• {"criterion_text":"- For prospective groups: Parental guardians affiliated with a social security system"}
• {"criterion_text":"- For prospective groups: Parental guardians who have signed an informed consent allowing their child to participate in the study"}
• {"criterion_text":"- For retrospective groups from CIRCUP : Parental guardians who are not opposed to their child's participation in the trial"}
• {"criterion_text":"- For prospective groups: Parental guardians giving consent must be able to understand the trial in its entirety"}

Exclusion criteria

• {"criterion_text":"- Long-term antibiotics use indicated for other reasons than PUV"}
• {"criterion_text":"- Mental state rendering the person giving consent incapable of understanding the trial"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Known contra-indication to all antibiotics used in the study (Alfatil®, Bactrim®, Augmentin®)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time-to-event analysis: time from baseline to first febrile urinary tract infection (fUTI) within 2 years. fUTI is defined as fever >38.5°C plus pyuria and culture-proven infection on urine obtained by urethral catheterization or suprapubic aspiration, together with biological signs of inflammation."}

Secondary endpoints

• {"endpoint_text":"- Median number of fUTIs at 2 years in children with at least 1 fUTI during follow-up","definition_or_measurement_approach":"Count and median of febrile UTI episodes over 2 years among children who experienced at least one fUTI during follow-up."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion comparison of children showing worsening on DMSA renal scan between baseline and 2 years; worsening defined as increased heterogeneity and increased number of cortical defects."}
• {"endpoint_text":"- The types of germs responsible for fUTIs","definition_or_measurement_approach":"Microbiological identification and description of pathogens isolated from culture-confirmed fUTIs."}
• {"endpoint_text":"- Baseline risk factors for fUTIs from regression models (exploratory)","definition_or_measurement_approach":"Exploratory regression modeling to identify baseline predictors of fUTI occurrence."}
• {"endpoint_text":"- Exploratory sub-group analyses in children with and without urinary reflux at baseline","definition_or_measurement_approach":"Subgroup comparative analyses stratified by presence/absence of urinary reflux at baseline."}
• {"endpoint_text":"- Adherence to antibiotic prophylaxis in the control group","definition_or_measurement_approach":"Assessment and description of adherence rates to daily antibiotic prophylaxis in control group over follow-up."}
• {"endpoint_text":"- Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis;and antibiotic prophylaxis alone respectively.","definition_or_measurement_approach":"Calculation of absolute risk differences for first fUTI between preventive strategies (circumcision alone vs circumcision + antibiotic prophylaxis; circumcision alone vs antibiotic prophylaxis alone) over 2 years."}

France

Earliest CTIS Part Ii Submission Date

16-05-2025

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

21

Number Of Sites

13

Number Of Participants

163

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France