Status:
RECRUITING
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pyelonephritis Acute
Eligibility:
All Genders
1-3 years
Phase:
PHASE4
Brief 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,...
Detailed Description
1.0 Hypothesis for the study Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 day...
Eligibility Criteria
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
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05544565
Start Date
March 22 2023
End Date
January 1 2028
Last Update
January 7 2026
Active Locations (15)
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1
CH Sud Francilien
Corbeil-Essonnes, Essonne, France, 91100
2
Paris-Saclay hospital
Orsay, Essonne, France, 91400
3
Antoine Beclère Hospital
Clamart, Haut de Seine, France, 92140
4
Ambroise Paré hospital
Boulogne, Hauts de Seine, France, 92100