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Study identifier: NCT05544565 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Pyelonephritis Acute  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 4
Planned participants480
Who can joinAll sexes, 1 Month to 3 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jean GASCHIGNARD, PhD  ·  +33 1 69 15 96 00  ·  j.gaschignard@ghne.fr

Romain BASMACI, PhD  ·  +33 1 47 60 63 58  ·  romain.basmaci@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (15)

CH Sud FrancilienCorbeil-Essonnes, Essonne, FranceNot Yet Recruiting
Paris-Saclay hospitalOrsay, Essonne, FranceRecruiting
Antoine Beclère HospitalClamart, Haut de Seine, FranceNot Yet Recruiting
Ambroise Paré hospitalBoulogne, Hauts de Seine, FranceRecruiting
Children-Teenager hospitalNantes, Loire Atlantique, FranceNot Yet Recruiting
Jeanne Flandre HospitalLille, Nord, FranceNot Yet Recruiting
Robert Debré HospitalParis, Paris, FranceNot Yet Recruiting
Robert Debré HospitalParis, Paris, FranceNot Yet Recruiting
Meaux HospitalMeaux, Seine et Marne, FranceNot Yet Recruiting
Jean Verdier HospitalBondy, Seine St Denis, FranceNot Yet Recruiting
Intercomunal Créteil HospitalCréteil, Val de Marne, FranceNot Yet Recruiting
Kremlin Bicêtre HospitalLe Kremlin-Bicêtre, Val de Marne, FranceNot Yet Recruiting

+ 3 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05544565