Efficacy and safety of individualised versus standard 10-day antibiotic treatment in children with febrile urinary tract infection (INDI-UTI): a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial in Denmark
Abstract
BACKGROUND
The optimal antibiotic duration for febrile urinary tract infection (UTI) in children remains uncertain. We aimed to assess whether individualised treatment was non-inferior to standard 10-day treatment in terms of recurrent UTI and superior in reducing overall antibiotic exposure.
METHODS
INDI-UTI was a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial conducted at eight Danish hospitals. Children aged 3 months to 12 years who were febrile (≥38°C), within 24 h of treatment start, and with significant growth of uropathogenic bacteria were randomly assigned (1:1) using a web-based module with randomly permuted blocks to individualised or standard 10-day treatment. Main exclusion criteria included known urinary tract abnormalities, complicated medical history, bacteraemia, and elevated serum creatinine. The individualised group stopped treatment 3 days after adequate clinical improvement (ie, absence of fever, flank pain, and dysuria), with a minimum treatment duration of 4 days. The primary outcomes were recurrent UTI within 28 days after treatment cessation (non-inferiority margin 7·5 percentage points) and total antibiotic days within 28 days of treatment initiation (superiority assessment). No sample size calculation was performed for the assessment of total antibiotic days. Safety was assessed in all included patients. Main analyses were done in the intention-to-treat population. This study is registered with ClinicalTrials.gov,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 408 participants or records.
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