3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children

Recruiting now · Phase 4

Conditions studied: Pyelonephritis Acute

In brief

Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 days) followed by the oral route, have a duration of 7 to 14 days (10 days in France). In children with no prior urological malformation, the global clinical and microbiological cure rate after antibiotic treatment completion is around 95%. Recurrence occurs in less than 5% of cases in the 3 months following AP. Renal scarring, when documented, concerns 15% of children 6 months after treatment. Renal scarring can be associated with chronic renal disease. The investigators hypothesize that 3 days of IV treatment is equivalent to extending to 10 days with an oral to treat AP in children. The investigators also hypothesize that while achieving equivalent clinical and prevention of re-infections in the following 3 months, 3 days of IV treatment reduces the risk of acquisition of resistant strains of Enterobacteriaceae and increases the gut microbotia diversity compared to extending to 10 days with an oral therapy.

Key facts

Study ID: NCT05544565
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 480
Starts: 2023-03-22
Expected to finish: 2028-01-01
Last updated by the study team: 2026-01-07

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 1 month and < 3 years
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 ≥ 10\^4/mL) with a positive urine culture with one Gram- negative bacillus ≥ 104 UFC/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/prendre-temperature); HAS (see: https://www.has-sante. fr/jcms/c_2674284/fr/prise-en-charge-de-la-fievre-chez-l-enfant)].
Initial treatment by either ceftriaxone AND/OR amikacin
Outpatient or hospitalised
Non-inclusion Criteria:
Urine collected by bag
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 other cephalosporins and other beta-lactams) and amikacin (including other aminoglycosids).
Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including other drugs containing sulfonamides) and cefixime (including other cephalosporins)
Known blood dyscrasias (megaloblastic haematopoiesis)
Known severe hepatic insufficiency
Known 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
Randomization criteria :

Where it is running

Andre mignot hospital — Le Chesnay, Yvelines, France (enrolling)
Paris-Saclay hospital — Orsay, Essonne, France (enrolling)
Ambroise Paré hospital — Boulogne, Hauts de Seine, France (enrolling)
Jeanne Flandre Hospital — Lille, Nord, France
Robert Debré Hospital — Paris, Paris, France
Robert Debré Hospital — Paris, Paris, France
Meaux Hospital — Meaux, Seine et Marne, France
Jean Verdier Hospital — Bondy, Seine St Denis, France
Intercomunal Créteil Hospital — Créteil, Val de Marne, France
Kremlin Bicêtre Hospital — Le Kremlin-Bicêtre, Val de Marne, France
GHEF Site Marne la vallée — Jossigny, France
CH Sud Francilien — Corbeil-Essonnes, Essonne, France
CHU Toulouse — Toulouse, France
Antoine Beclère Hospital — Clamart, Haut de Seine, France
Children-Teenager hospital — Nantes, Loire Atlantique, France

Full record on ClinicalTrials.gov

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