Clinical efficacy of single dose (daily) IV antibiotics followed by 2 days oral antibiotics compared to 3 doses (daily) IV antibiotics for children with complicated urinary tract infections: a multicentre randomised trial

Complicated urinary tract infections are common reasons for hospital admissions and constitute a major burden for healthcare systems. However, research into the optimal treatment for children with urinary tract infections have only focused on those with an uncomplicated clinical course, neglecting those with a more complicated course. This trial aims to investigate the optimal treatment for this group, single dose IV plus 2 days oral antibiotics or 3 days of IV antibiotics. Patients are aged 3 months to 18 years who have presented to the ED with a UTI and ≥3 complicated features (history of recurrent UTI, urological abnormalities, fever, vomiting, rigors and tachycardia) are eligible.
Methods: Randomisation to receive single dose of intravenous antibiotics (and 2days oral antibiotics) or 3 days of IV antibiotics. At 72 hours after initial IV dose, clinical failure is defined as persistence of baseline symptoms (fever or vomiting or rigors) or development of new symptoms (fever or vomiting or rigors) attributed to UTI.
Expected outcomes:Proportion of children with clinical failure is similar in both groups. Children with UTI will only need a single dose IV and rapidly switch to oral antibiotics.