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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
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.
Standard antibiotic therapy is 10 days of antibiotic therapy regardless of the duration of illness after treatment initiation.
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Copenhagen University Hospital Herlev
Herlev, Denmark
Copenhagen University Hospital Hillerød
Hillerød, Denmark
Copenhagen University Hospital Holbæk
Holbæk, Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark
Copenhagen University Hospital Nykøbing Falster
Nykøbing Falster, Denmark
Copenhagen University Hospital Roskilde
Roskilde, Denmark
Copenhagen University Hospital Slagelse
Slagelse, Denmark
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time frame: within 28 days after end of treatment
Number of days with antibiotic therapy
Time frame: within 28 days after treatment initiation
Number of days with absence from school or daycare due to illness
Time frame: within 28 days after randomization
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Time frame: within 100 days after end of treatment
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