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RECRUITING
NCT05544565
PHASE4

3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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, 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.

Official title: 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

Key Details

Gender

All

Age Range

1 Month - 3 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2023-03-22

Completion Date

2028-01

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

IV Antibacterial Agents

Ceftriaxone (50 mg/kg once a day by intravenous/intramuscular route) AND/OR Amikacin (20 mg/kg once a day by intravenous/intramuscular route) during 3 days. .

DRUG

Orally antibacterial agents

Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days

PROCEDURE

Fecal/Rectal Swab

Collected by the nurse or the physician (D0,D3,D10 or 17 and D31 or D38), either by a rectal swab, either by fecal swab (dip of the swab in fresh stools \< 4 hours, which will occur frequently in our population of children aged 1 month to 3 years, and will in particular be possible for hospitalized children) using a FecalSwabTM, that contains a transport medium.

PROCEDURE

PCT assay

Dosage of procalcitonin (if not performed in standard care) at D0

Locations (15)

CH Sud Francilien

Corbeil-Essonnes, Essonne, France

Paris-Saclay hospital

Orsay, Essonne, France

Antoine Beclère Hospital

Clamart, Haut de Seine, France

Ambroise Paré hospital

Boulogne, Hauts de Seine, France

Children-Teenager hospital

Nantes, Loire Atlantique, France

Jeanne Flandre Hospital

Lille, Nord, France

Robert Debré Hospital

Paris, Paris, France

Robert Debré Hospital

Paris, Paris, France

Meaux Hospital

Meaux, Seine et Marne, France

Jean Verdier Hospital

Bondy, Seine St Denis, France

Intercomunal Créteil Hospital

Créteil, Val de Marne, France

Kremlin Bicêtre Hospital

Le Kremlin-Bicêtre, Val de Marne, France

Andre mignot hospital

Le Chesnay, Yvelines, France

GHEF Site Marne la vallée

Jossigny, France

CHU Toulouse

Toulouse, France