Actively Recruiting
3-day Intravenous Antibiotic Treatment Versus 3-day Intravenous Followed by 7-day Oral Antibiotic Treatment for Acute Pyelonephritis in Children 1 Month to 3 Years Old: a Non-inferiority Open Randomized Multicentric Clinical Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-07
480
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate antibiotic treatments for acute pyelonephritis (AP) in children aged 1 month to 3 years. It compares a shorter intravenous (IV) antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone and/or amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.
CONDITIONS
Brief 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 or older and 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 386C or higher on diagnosis day and positive urine test with one Gram-negative bacillus at 10^4 colony forming units/mL or more
- Initial treatment with intravenous 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 kidney or urinary tract anomalies except vesicoureteral reflux or pyelocaliceal dilatation under 10 mm
- Previous genitourinary tract surgery except circumcision
- Abnormal kidney function for age and weight
- Known immunocompromising conditions such as HIV, primary immunodeficiency, sickle cell disease, or chronic immunosuppressive treatment
- Antibiotic prophylaxis or antibiotic treatment in last 7 days except for current acute pyelonephritis
- Known hypersensitivity to ceftriaxone, amikacin, cotrimoxazole, cefixime, or related antibiotics
- Known blood disorders or severe liver failure
- Known G6PD deficiency
- No written parental consent
- Not affiliated with social security system
- Follow-up not conducted at study center
- Participation in another interventional or minimal risk trial
- Randomization requires 3 days of continuous antibiotic intake, positive urine culture with Gram-negative bacillus, favorable clinical outcome at randomization with temperature below 386C for at least 12 hours, no abdominal pain or feeding problems, no renal abscess or kidney anomalies on ultrasound, one dominant bacteria type only, sensitivity to initial antibiotic and to cefixime or cotrimoxazole
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 10 days depending on group assignment
Participants receive antibiotic treatment for acute pyelonephritis. One group receives 3 days of intravenous antibiotics only, while the other group receives 3 days of intravenous antibiotics followed by 7 days of oral antibiotics.
1 to 2 visits during treatment period depending on group
Duration - Up to 38 days after treatment completion
Participants are monitored for clinical cure, recurrence of infection, colonization with resistant bacteria, and intestinal microbiota diversity after treatment completion.
Multiple visits at days 10 or 17 and days 31 or 38 depending on group
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
R
Romain BASMACI, PhD
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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