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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 PYELOCOURT
EU CTIS ID: 2024-518930-10-00
What this study is testing
The main objective is to demonstrate the non-inferiority of treating AP in children by a 3-day intravenous (IV) antibiotic therapy versus a 3-day IV therapy followed by a 7-day oral antibiotic therapy, comparing the rate of recurrence of febrile urinary tract infection within the 28-day period after the completion of antibiotic treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Age ≥ 1 month and < 3 years o 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 ≥ 104/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/prendretemperature); 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
You likely can't join if
- - Urine collected by bag
- - Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)
- - Known severe hepatic insufficiency
- - Known complete G6PD deficiency
- - No written consent from holders of parental authority
- - Non-affiliation to a social security system (as beneficiary or entitled person)
See the full eligibility criteria
- - Age ≥ 1 month and < 3 years o 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 ≥ 104/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/prendretemperature); 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
- - Urine collected by bag
- - Known hypersensitivity to 99mTc-DMSA (medicinal product used for renal scintigraphy)
- - Known severe hepatic insufficiency
- - Known complete 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
- - 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 cephalosporin and beta-lactams) and amikacin (including aminoside)
- - Known hypersensitivity to at least one of the active substances /excipients: cotrimoxazole (=sulfamethoxazole/trimethoprim) (including sulfonamide) and cefixime (including cephalosporin)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.