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Recruiting Phase 4

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

NCT05544565 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2023-03-22
Last updated
2026-01-07

Condition(s) studied

Pyelonephritis Acute

Investigational drug(s) / intervention(s)

IV Antibacterial AgentsOrally antibacterial agentsFecal/Rectal SwabPCT assay

IV Antibacterial Agents: Ceftriaxone (50 mg/kg once a day by intravenous/intramuscular route) AND/OR Amikacin (20 mg/kg once a day by intravenous/intramuscular route) during 3 days. .

Orally antibacterial agents: Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days

Fecal/Rectal Swab: Collected by the nurse or the physician (D0,D3,D10 or 17 and D31 or D38), either by a rectal swab, either by fecal swab (dip of the swab in fresh stools \< 4 hours, which will occur frequently in our population of children aged 1 month to 3 years, and will in particular be possible for hospitalized children) using a FecalSwabTM, that contains a transport medium.

PCT assay: Dosage of procalcitonin (if not performed in standard care) at D0

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
3 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence of febrile urinary tract infection — 28 days (± 3 days) after the completion of antibiotic treatment.
    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 in term of the is recurrence of febrile urinary tract infection within a 28 -days period after the completion of antibiotic treatment respectively at D31 (+/- 3 days) for the experimental group and D38 (+/- 3 days) for the control group.. The recurrence will be defined as: fever ≥ 38°C associated with a positive urinalysis (white cell counts ≥ 10\^4/mL) with a positive urine culture with one Gram-negative bacillus ≥ 10\^4 UFC/mL

Trial sites (15)

FacilityCityRegionStatus
CH Sud Francilien Corbeil-Essonnes Essonne Not Yet Recruiting
Paris-Saclay hospital Orsay Essonne Recruiting
Antoine Beclère Hospital Clamart Haut de Seine Not Yet Recruiting
Ambroise Paré hospital Boulogne Hauts de Seine Recruiting
Children-Teenager hospital Nantes Loire Atlantique Not Yet Recruiting
Jeanne Flandre Hospital Lille Nord Not Yet Recruiting
Robert Debré Hospital Paris Paris Not Yet Recruiting
Robert Debré Hospital Paris Paris Not Yet Recruiting
Meaux Hospital Meaux Seine et Marne Not Yet Recruiting
Jean Verdier Hospital Bondy Seine St Denis Not Yet Recruiting
Intercomunal Créteil Hospital Créteil Val de Marne Not Yet Recruiting
Kremlin Bicêtre Hospital Le Kremlin-Bicêtre Val de Marne Not Yet Recruiting
Andre mignot hospital Le Chesnay Yvelines Recruiting
GHEF Site Marne la vallée Jossigny France Not Yet Recruiting
CHU Toulouse Toulouse France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05544565 on ClinicalTrials.gov ↗ ← All trials in France