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

RecruitingPhase 4Ages 1 Month - 3 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 : * Three days of taking antibiotics (IV or IM) (no interruption or discontinuation) * Positive urine culture with Gram negative bacillus ≥ 10\^4 UFC/mL * Favorable clinical outcome at day of randomization (D2 or D3) defined by temperature \< 38°C at day of randomization and absence of fever measured \> 38°C for at least 12 hours AND no abdominal pain AND no feeding problem AND investigator agreement * No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \< 10 mm) on the renal ultrasound performed between D0 and day of randomization * No more than 1 type of dominant bacteria on the urine culture * Sensitivity to the initial antibiotic treatment * Sensitivity to cefixime OR cotrimoxazole
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What it tests

  • IV Antibacterial Agents
  • Orally antibacterial agents
  • Fecal/Rectal Swab
  • PCT assay
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Where

15 sites
CH Sud Francilien
Corbeil-Essonnes, France
Paris-Saclay hospital
Orsay, France
Antoine Beclère Hospital
Clamart, France
Ambroise Paré hospital
Boulogne, France
Children-Teenager hospital
Nantes, France
Jeanne Flandre Hospital
Lille, France
Robert Debré Hospital
Paris, France
Robert Debré Hospital
Paris, France

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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