Actively Recruiting
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-07
480
Participants Needed
15
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 month to less than 3 years
- For children younger than 3 months, gestational age greater than 34 weeks
- First episode of urinary tract infection
- Acute pyelonephritis defined by temperature of at least 38°C on diagnosis day and positive urinalysis (white cell counts ≥ 10^4/mL) with a urine culture showing one Gram-negative bacillus ≥ 10^4 UFC/mL
- Initial treatment by ceftriaxone and/or amikacin
- Outpatient or hospitalized status
You will not qualify if you...
- Urine collected by bag
- Urine culture growing more than one dominant bacterium
- Catheter-associated acute pyelonephritis
- Known congenital anomalies of the kidney and genitourinary tract other than vesicoureteral reflux and pyelocaliceal dilatation less than 10 mm
- Previous surgery of the genitourinary tract except circumcision in male children
- Abnormal renal function for age and weight (serum creatinine >40 µmol/L before 1 year and >75 µmol/L between 1 and 3 years)
- Known immunocompromising conditions (e.g., HIV, primary immunodeficiency, sickle cell disease, chronic corticosteroids or other immunosuppressants use)
- Antibiotic prophylaxis for any reason or antibiotic treatment in the last 7 days except for acute pyelonephritis
- Known hypersensitivity to ceftriaxone, amikacin, cotrimoxazole, or cefixime
- Known blood disorders (megaloblastic haematopoiesis)
- Known severe liver failure
- Known G6PD deficiency
- No written consent from parental authority holders
- Non-affiliation to social security system
- Follow-up not performed at the study center
- Participation in another interventional or minimal risk trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
CH Sud Francilien
Corbeil-Essonnes, Essonne, France, 91100
Not Yet Recruiting
2
Paris-Saclay hospital
Orsay, Essonne, France, 91400
Actively Recruiting
3
Antoine Beclère Hospital
Clamart, Haut de Seine, France, 92140
Not Yet Recruiting
4
Ambroise Paré hospital
Boulogne, Hauts de Seine, France, 92100
Actively Recruiting
5
Children-Teenager hospital
Nantes, Loire Atlantique, France, 44000
Not Yet Recruiting
6
Jeanne Flandre Hospital
Lille, Nord, France, 59000
Not Yet Recruiting
7
Robert Debré Hospital
Paris, Paris, France, 75019
Not Yet Recruiting
8
Robert Debré Hospital
Paris, Paris, France, 75019
Not Yet Recruiting
9
Meaux Hospital
Meaux, Seine et Marne, France, 77100
Not Yet Recruiting
10
Jean Verdier Hospital
Bondy, Seine St Denis, France, 93140
Not Yet Recruiting
11
Intercomunal Créteil Hospital
Créteil, Val de Marne, France, 94000
Not Yet Recruiting
12
Kremlin Bicêtre Hospital
Le Kremlin-Bicêtre, Val de Marne, France, 94270
Not Yet Recruiting
13
Andre mignot hospital
Le Chesnay, Yvelines, France, 78150
Actively Recruiting
14
GHEF Site Marne la vallée
Jossigny, France
Not Yet Recruiting
15
CHU Toulouse
Toulouse, France
Not Yet Recruiting
Research Team
J
Jean GASCHIGNARD, PhD
CONTACT
R
Romain BASMACI, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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