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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
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
Conditions
Interventions
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. .
Orally antibacterial agents
Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days
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.
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