Could 3 days of IV antibiotics be enough for Kids' kidney infections?

NCT ID NCT05544565

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two antibiotic treatments for acute kidney infection in children aged 1 month to 3 years. One group gets 3 days of IV antibiotics only, while the other gets 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter course works just as well at preventing the infection from coming back within a month, while possibly reducing antibiotic resistance. About 480 children will take part across multiple hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: antibiotics (ceftriaxone, amikacin, cotrimoxazole, or cefixime)
What this could lead to: If it works, this could show that a shorter antibiotic course is just as effective, reducing side effects and antibiotic resistance in young children.
What could go wrong: This is a phase 4 trial, but it's still recruiting and results are not yet known. The shorter course might not prevent infection recurrence as well as the longer one.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 3 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pyelonephritis acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

15 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ambroise Paré hospital
RECRUITING

Boulogne, Hauts de Seine, 92100, France
Andre mignot hospital
RECRUITING

Le Chesnay, Yvelines, 78150, France
Antoine Beclère Hospital
NOT_YET_RECRUITING

Clamart, Haut de Seine, 92140, France
CH Sud Francilien
NOT_YET_RECRUITING

Corbeil-Essonnes, Essonne, 91100, France
CHU Toulouse
NOT_YET_RECRUITING

Toulouse, France
Children-Teenager hospital
NOT_YET_RECRUITING

Nantes, Loire Atlantique, 44000, France
GHEF Site Marne la vallée
NOT_YET_RECRUITING

Jossigny, France
Intercomunal Créteil Hospital
NOT_YET_RECRUITING

Créteil, Val de Marne, 94000, France
Jean Verdier Hospital
NOT_YET_RECRUITING

Bondy, Seine St Denis, 93140, France
Jeanne Flandre Hospital
NOT_YET_RECRUITING

Lille, Nord, 59000, France
Kremlin Bicêtre Hospital
NOT_YET_RECRUITING

Le Kremlin-Bicêtre, Val de Marne, 94270, France
Meaux Hospital
NOT_YET_RECRUITING

Meaux, Seine et Marne, 77100, France
Paris-Saclay hospital
RECRUITING

Orsay, Essonne, 91400, France
Robert Debré Hospital
NOT_YET_RECRUITING

Paris, Paris, 75019, France
Robert Debré Hospital
NOT_YET_RECRUITING

Paris, Paris, 75019, France

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