TOPLINE:
In children with febrile urinary tract infections (UTIs), an individualised antibiotic treatment regimen stopped 3 days after the achievement of adequate clinical improvement increased the risk for recurrent infections but reduced antibiotic use and adverse event days compared with the standard 10-day regimen.
METHODOLOGY:
- Researchers conducted a pragmatic trial (INDI-UTI) to evaluate whether individualised antibiotic treatment was non-inferior to standard 10-day treatment in terms of recurrent UTIs and superior in reducing overall exposure to antibiotics.
- A total of 408 patients (median age, 1.5 years; 80% girls) with UTIs who were febrile (≥ 38 °C) and had significant growth of uropathogenic bacteria were included and were randomly assigned to either the individualised treatment group (n = 205) or the standard 10-day treatment group (n = 203).
- The individualised group received antibiotics for a minimum of 4 days, stopping treatment at 3 days after achievement of adequate clinical improvement, whereas the standard group received antibiotics for a full 10 days.
- Treatment options included oral amoxicillin-clavulanic acid, oral mecillinam, or intravenous ampicillin and gentamicin.
- The primary outcomes were recurrent UTIs within 28 days after treatment cessation and the total number of antibiotic days within 28 days of treatment initiation.
TAKEAWAY:
- The median antibiotic duration for the baseline infection was 5.3 days (interquartile range [IQR], 4.8-6.5) in the individualised group and 10.0 days (IQR, 10.0-10.0) in the standard group.
- Recurrent UTIs within 28 days occurred in a higher proportion of patients in the individualised group than in those in the standard group (11% vs 6%; difference, 5.3 percentage points; Pnon-inferiority = .24), failing to establish the non-inferiority of the individualised antibiotic regimen.
- However, the risk for recurrence with individualised vs standard antibiotic regimen appeared to equalise within 100 days of treatment cessation, with a difference of 1.8 percentage points (Pnon-inferiority = .012).
- The incidence rate of antibiotic-related adverse events within 28 days was lower in the individualised group than in the standard group (rate ratio, 0.61; P = .0003).
IN PRACTICE:
"Given that most children responded well to shorter treatment, and even those requiring retreatment for non-febrile recurrences often had a total antibiotic duration shorter than that of children receiving standard 10-day treatment, the benefits of reduced antibiotic exposure could outweigh the increased risk of recurrence. Further research is needed to identify children at higher risk of recurrence to avoid compromising their outcomes," the authors wrote.
"The INDI-UTI trial is a crucial step in the right direction. Now that shorter therapy is standard for many infections, the next challenge is learning how to tailor treatment duration to the individual patient," experts wrote in an accompanying editorial.
SOURCE:
This study was led by Naqash Javaid Sethi, MD, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. It was published online on April 02, 2025, in The Lancet Infectious Diseases.
LIMITATIONS:
This trial did not mask treatment allocation. The study adhered solely to Danish guidelines, which may have affected the accuracy of UTI diagnosis. Furthermore, it did not assess the impact of antibiotic treatment duration on the intestinal or urinary microbiome.
DISCLOSURES:
This study was supported by the Copenhagen University Hospital Rigshospitalet Research Fund, Innovation Fund Denmark, and Greater Copenhagen Health Science Partners. The authors declared having no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
