Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infe… (NCT05301023) | Clinical Trial Compass
CompletedPhase 4
Individualized Antibiotic Therapy in Children With Acute Uncomplicated Febrile Urinary Tract Infection
Denmark408 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range3 Months – 12 Years
SexALL
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Inclusion criteria
✓. Clinical suspicion of febrile (≥38 °C) urinary tract infection.
✓. Positive urine culture of uropathogenic bacteria obtained by either suprapubic bladder aspiration, sterile intermittent catheterization, or midstream urine.
✓. Suprapubic bladder aspiration: any growth of bacteria.
✓. Sterile intermittent catheterization: monoculture with ≥10\^3 cfu/ml.
✓. Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10\^4 cfu/ml.
✓. Midstream urine x 2: Monoculture with the bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test.
✓. Midstream urine x 1 (≥10 years of age): Monoculture with ≥10\^5 cfu/ml.
✓. 3 months to 13 years of age (corrected age in case of premature birth).
Exclusion criteria
✕. Non-Danish civil registration number.
What they're measuring
1
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
Timeframe: within 28 days after end of treatment
2
Number of days with antibiotic therapy
Timeframe: within 28 days after treatment initiation