drugset / Trial / NCT05544565

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

NCT05544565

Phase 4 Recruiting 480 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-22
Primary completion
2028-01
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefixime Other / unclassified 8 mg/kg Oral
Subject trimethoprim-sulfamethoxazole Unknown 30 mg/kg Oral
Background Amikacin Small molecule 20 mg/kg Intravenous
Background Ceftriaxone Other / unclassified 50 mg/kg Intravenous

Indications