2024-518930-10-00Not yet recruitingPhase 3
PYELOCOURT - 3-day intravenous antibiotic treatment versus 3-day intravenous followed by 7-day oral antibiotic treatment for acute pyelonephritis in children 1 month to 3 years old: a non-inferiority open randomized multicentric clinical trial
Assistance Publique Hopitaux De Paris1 site in 1 country588 target enrollmentStarted: November 26, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 588
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the occurrence of renal scaring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy at 6 months after the beginning of therapy (day 180 ± 15 days).
Study Overview
Brief Summary
The main objective is to demonstrate the non-inferiority of a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy for the treatment of AP in children on the occurrence of renal scarring.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 1 month and < 3 years o For children younger than 3 months, gestational age > 34 WA
- •First episode of urinary tract infection
- •AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 104/mL)
- •Initial treatment by either ceftriaxone AND/OR amikacin
- •Outpatient or hospitalised
Exclusion Criteria
- •Urine collected by bag
- •Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)
- •Known severe hepatic insufficiency
- •Known complete G6PD deficiency
- •No written consent from holders of parental authority
- •Non-affiliation to a social security system (as beneficiary or entitled person)
- •Children whose follow-up is not carried out in the centre
- •Participation in another interventional or minimal risk trial
- •Urine culture growing more than one dominant bacterium (cf section 6.2 of the protocol) Catheter-associated acute pyelonephritis
- •Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation < 10 mm)
- •Previous surgery of the genitourinary tract (except circumcision in male children)
- •Abnormal renal function for age and weight (defined by a serum creatinine >40µmol/L before 1 year and >75µmol between 1 year et 3 years)
- •Known immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)
- •Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)
- •Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (including cephalosporin and beta-lactams) and amikacin (including aminoside)
- •Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including sulfonamide) and cefixime (including cephalosporin)
Outcomes
Primary Outcomes
The primary endpoint is the occurrence of renal scaring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy at 6 months after the beginning of therapy (day 180 ± 15 days).
The primary endpoint is the occurrence of renal scaring, as measured by cortical defect by dimercaptosuccinic acid (99mTc-DMSA) renal scintigraphy at 6 months after the beginning of therapy (day 180 ± 15 days).
Secondary Outcomes
- - Clinical cure at the end of the antibiotic treatment (day 14 ± 3 days), defined by apyrexia AND no abdominal pain AND no feeding problem: medical visit.
- Recurrent infection (including AP relapse or reinfection) within 90 days after the beginning of therapy (day 90 ± 15 days): phone call
- Colonization with antimicrobial resistant Enterobacteriaceae in the gastrointestinal tract at days of randomization and 14.
- Alpha-diversity measured by Shannon’s index at inclusion, randomization, , 14 and 45.
Investigators
Dr Jean GASCHIGNARD
Scientific
Assistance Publique Hopitaux De Paris
Study Sites (1)
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