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 PYELOCOURT

Phase 3

Not yet recruiting

• Conditions: acute pyelonephritis (AP) in children

• Registration Number: 2024-518930-10-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 588

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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.		- 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		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.		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.		Alpha-diversity measured by Shannon’s index at inclusion, randomization, , 14 and 45.

Trial Locations

Locations (1)

Groupe Hospitalier Nord Essonne; 🇫🇷 Orsay, France

Groupe Hospitalier Nord Essonne

🇫🇷Orsay, France

Jean GASCHIGNARD

Site contact

0165543392

j.gaschignard@ghne.fr