NCT05301023

Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection

Individualized Antibiotic Therapy Versus Standard Care in Children With Febrile Urinary Tract Infection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

An investigator-initiated, open-label, multi-center, randomized, non-inferiority trial of children aged 3 months to 13 years with acute uncomplicated febrile urinary tract infection. The primary objective is to determine whether individualized antibiotic therapy based on an algorithm (experimental arm) versus standard antibiotic therapy of 10 days (control arm) can reduce the number of days with antibiotic therapy within 28 days after treatment initiation without increasing the risk of recurrent urinary tract infection regardless of the pathogen or death of any cause within 28 days after end of treatment. Children will be randomized 1:1. The medical treatments received are identical in both groups.

Conditions

• Febrile Urinary Tract Infection

Interventions

Type	Name	Description
OTHER	Individualized antibiotic therapy	Individualized antibiotic therapy is based on the duration of illness after treatment initiation, as the antibiotic therapy can be stopped three days after the participant has become healthy. The participant is classified as healthy if he/she is afebrile (\<38.0 °C), has experienced significant clinical improvement, and have no flank pains or dysuria.
OTHER	Standard antibiotic therapy	Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-02-29
• Completion: 2024-06-08
• First posted: 2022-03-29
• Last updated: 2024-07-08

Locations

8 sites across 1 country: Denmark