AMIKACIN SULFATE for Acute pyelonephritis

Inclusion criteria

• {"criterion_text":"- Age ≥ 1 month and < 3 years o\t For children younger than 3 months, gestational age > 34 WA"}
• {"criterion_text":"- First episode of urinary tract infection"}
• {"criterion_text":"- AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 104/mL).The child temperature will have to be measured with a thermometer according to the French national recommendations [Health Insurance website (AMELI ;see: - https://www.ameli. fr/assure/sante/bons-gestes/soins/prendretemperature); HAS (see: https://www.has-sante. fr/jcms/c_2674284/fr/prise-en-charge-de-la-fievre-chez-l-enfant)]."}
• {"criterion_text":"- Initial treatment by either ceftriaxone AND/OR amikacin"}
• {"criterion_text":"- Outpatient or hospitalised"}

Exclusion criteria

• {"criterion_text":"-\tUrine collected by bag"}
• {"criterion_text":"-\tUrine culture growing more than one dominant bacterium (cf section 6.2 of the protocol) Catheter-associated acute pyelonephritis"}
• {"criterion_text":"-\tKnown congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm)"}
• {"criterion_text":"-\tPrevious surgery of the genitourinary tract (except circumcision in male children)"}
• {"criterion_text":"-\tAbnormal renal function for age and weight (defined by a serum creatinine >40µmol/L before 1 year and >75µmol between 1 year et 3 years)"}
• {"criterion_text":"-\tKnown immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)"}
• {"criterion_text":"-\tAntibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)"}
• {"criterion_text":"-\tKnown hypersensitivity to at least one of the active substances /excipients: ceftriaxone (including cephalosporin and beta-lactams) and amikacin (including aminoside)"}
• {"criterion_text":"-\tKnown hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including sulfonamide) and cefixime (including cephalosporin)"}
• {"criterion_text":"-\tKnown hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)"}
• {"criterion_text":"-\tKnown severe hepatic insufficiency"}
• {"criterion_text":"-\tKnown complete G6PD deficiency"}
• {"criterion_text":"-\tNo written consent from holders of parental authority"}
• {"criterion_text":"-\tNon-affiliation to a social security system (as beneficiary or entitled person)"}
• {"criterion_text":"-\tChildren whose follow-up is not carried out in the centre"}
• {"criterion_text":"-\tParticipation in another interventional or minimal risk trial"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint isrecurrence of febrile urinary tract infection within a 28 days period after the end completion of antibiotic treatment respectively at D31 (+/- 3 days) for the experimental group and D38 (+/- 3 days) for the control group.","definition_or_measurement_approach":"Recurrence of febrile urinary tract infection within 28 days after completion of antibiotic treatment; assessed at D31 (±3 days) for the experimental group and D38 (±3 days) for the control group."}

Secondary endpoints

• {"endpoint_text":"- Clinical cure 7 days after end of treatment, defined by apyrexia AND absence of signs suggestive of urinary infection (abdominal pain, urinary function signs) AND no feeding problem collected during a medical visit, respectively at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group.","definition_or_measurement_approach":"Clinical cure defined by apyrexia AND absence of signs suggestive of urinary infection (abdominal pain, urinary function signs) AND no feeding problems; assessed at D10 (±3 days) for experimental arm and D17 (±3 days) for control; evaluated during medical visit."}
• {"endpoint_text":"- Recurrent of AP within 90 days after the beginning of therapy (day 90 ± 15 days) collected during a phone call.","definition_or_measurement_approach":"Recurrence of acute pyelonephritis within 90 days after therapy start (day 90 ±15 days); collected by telephone follow-up."}
• {"endpoint_text":"- Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract at days of randomization and at D10 (+/- 3 days) for the experimental group and D17 (+/- 3 days) for the control group","definition_or_measurement_approach":"Presence/colonization by antimicrobial-resistant Enterobacteriaceae in GI tract measured at randomization and at specified post-treatment days (D10 ±3 for experimental; D17 ±3 for control)."}
• {"endpoint_text":"- Alpha-diversity measured by Shannon’s index at inclusion, randomization, and at D10 (+/- 3 days) and D31 (+/- 3 days) for the experimental group, and D17 (+/- 3 days) and D38 (+/- 3 days) for the control group .","definition_or_measurement_approach":"Microbiota alpha-diversity quantified using Shannon's index at inclusion, randomization, and specified follow-up days for each arm (D10/D31 for experimental; D17/D38 for control)."}

France

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

12-12-2025

Processing Time Days

382

Number Of Sites

2

Number Of Participants

480

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France