Abstract
BackgroundThis study aimed to evaluate the effect of oral dexamethasone in reducing kidney scars in infants with a first febrile urinary tract infection (UTI).MethodsChildren aged between 2 and 24 months with their first presumed UTI, at high risk for kidney scarring based on procalcitonin levels (≥1 ng/mL), were randomly assigned to receive dexamethasone in addition to routine care or routine care only. Kidney scars were identified by kidney scan at 6 months after initial UTI. Projections of enrollment and follow-up completion showed that the intended sample size could not be reached before funding and time to complete the study ran out. An amendment to the protocol was approved to conduct a Bayesian analysis.ResultsWe randomized 48 children, of whom 42 had a UTI and 18 had outcome kidney scans (instead of 128 planned). Kidney scars were found in 0/7 and 2/11 patients in the treatment and control groups respectively. The probability that dexamethasone could prevent kidney scarring was 99% in the setting of an informative prior probability distribution (which fully incorporated in the final inference the information on treatment effect provided by previous studies) and 98% in the low-informative scenario (which discounted the prior literature information by 50%). The probabilities that dexamethasone could reduce kidney scar formation by up to 20% were 61% and 53% in the informative and low-informative scenario, respectively.ConclusionsDexamethasone is highly likely to reduce kidney scarring, with a more than 50% probability to reduce kidney scars by up to 20%.Trial registration numberEudraCT number: 2013-000388-10; registered in 2013 (prospectively registered)Graphical A higher resolution version of the Graphical abstract is available as Supplementary information
Highlights
Kidney scarring can occur in 10 to 40% of children with a urinary tract infection (UTI) despite appropriate antibiotic treatment [1, 2]
In 2011, a randomized controlled trial (RCT) including children with pyelonephritis confirmed on acute 99m-Tcdimercaptosuccinic acid (DMSA) scan found that adjuvant oral methylprednisolone was associated with a lower kidney scarring rate compared with the control group (33.3% versus 60%)
Children aged 2 to 24 months with the first episode of presumed febrile UTI at high risk of kidney scarring based on PCT levels ≥ 1 ng/mL were eligible for enrolment
Summary
Kidney scarring can occur in 10 to 40% of children with a urinary tract infection (UTI) despite appropriate antibiotic treatment [1, 2]. While risk factors are still largely unknown, the inflammatory process, rather than the bacterial component, seems responsible for the permanent tissue damage of the kidney [6, 7] On this basis, anti-inflammatory agents, such as steroids, were studied in animal models showing a reduction in scar development [8, 9]. In 2011, a randomized controlled trial (RCT) including children with pyelonephritis confirmed on acute 99m-Tcdimercaptosuccinic acid (DMSA) scan found that adjuvant oral methylprednisolone was associated with a lower kidney scarring rate compared with the control group (33.3% versus 60%). This study aimed to evaluate the effect of oral dexamethasone in reducing kidney scars in infants with a first febrile urinary tract infection (UTI). The probabilities that dexamethasone could reduce kidney scar formation by up to 20% were 61% and 53% in the informative and low-informative scenario, respectively
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