Antibiothérapie intraveineuse de 3 jours versus antibiothérapie intraveineuse de 3 jours suivie d'une antibiothérapie orale de 7 jours pour la pyélonéphrite aiguë chez les enfants de 1 mois à 3 ans : essai clinique multicentrique randomisé ouvert de non-infériorité

Phase 1

• Conditions: Acute pyelonephritis in children 1 month to 3 years old; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2021-005627-21-FR
• Lead Sponsor: APHP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-30
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

- 1 month = Age < 3 years
- For children younger than 3 months, gestational age > 34 WGA
- First episode of urinary tract infection.
- AP defined by temperature = 38°C on day of diagnosis AND positive urinalysis (white cell counts = 104/mL) AND Gram-negative rods in Gram-stained urine
- Initial treatment by either ceftriaxone AND/OR amikacin.
- Outpatient or hospitalised

Are the trial subjects under 18? yes
Number of subjects for this age range: 558
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Urine collected by bag.
-Urine culture growing more than one bacteria.
-Catheter-associated AP.
-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
-Immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents).
-A history of AP or other urinary tract infection.
-Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days.
-Known hypersensitivity to at least one of the active substances /excipients: ceftriaxone (include cephalosporin et beta-lactams)and amikacin (include aminoside)Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (include sulfonamide) and cefixime (include cephalosporin)
-Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)
-Severe hepatic insufficiency (transaminases = 3N)
-Known G6PD deficiency
-No written consent from holders of parental authority, or refusal of the child to participate
-Non-affiliation of the child in a social security (as beneficiary or entitled person)
-Children whose follow-up is not carried out in the centre
-Participation in another interventional or minimal risk trial

Study & Design

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