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

UTI is the most common reason in the developed world for children to need antibiotics, accounting for 12% of preventable hospitalisations across all age groups. The most frequent reason for children with UTI requiring hospitalisation is for IV antibiotics which is a major burden for healthcare systems. For those without complicating factors, there is good evidence for treatment with oral antibiotics at home. For children with complications such as vomiting and urological abnormalities, there is little evidence for route of antibiotic treatment or treatment duration because previous trials have excluded this cohort. This trial aims to investigate whether single dose of parenteral antibiotics followed by 2 days oral antibiotics is non-inferior to three doses for children with UTI and co-existing complicating factors presenting to the ED.

Study design

This study is an open label, multi-centre, non-inferiority randomised controlled trial (RCT). It incorporates a two-arm, non-inferiority design with parallel arms and 1:1 allocation of children presenting to the ED with a febrile complicated UTI treated with parenteral antibiotics.

Chief Investigators

Dr Laila Ibrahim, Royal Children’s Hospital Melbourne
A/Prof Penelope Bryant, Royal Children’s Hospital Melbourne
Prof Franz Babl, Royal Children’s Hospital Melbourne
Dr Sarah McNab, Royal Children’s Hospital Melbourne
Prof Meredith Borland, Perth Children’s Hospital
Prof Stuart Dalziel, Starship Children’s Hospital (Auckland)
Prof Simon Craig, Monash Health
Dr Amit Kochar, Women’s and Children’s Hospital (Adelaide)




The Royal Children’s Hospital Foundation Research Grant 2016-718.
National Health and Medical Research Council MRFF Research Grant MRF1200411.

Site locations

  • Royal Children’s Hospital, Melbourne  – lead hospital (CPI Laila Ibrahim)
  • Women and Children’s Hospital, Adelaide – (PI Amit Kochar)
  • Monash Medical Centre, Melbourne (PI Simon Craig)
  • Perth Children’s Hospital, Perth (PI Meredith Borland)
  • Starship Children’s Hospital, Auckland (PI Stuart Dalziel)


A total of 452 children aged 3 months to 18 years will be enrolled and randomised in the study (approximately 226 per treatment arm).

Trial Registration, ID NCT04876131


Laila Ibrahim (CPI)
Emily McKie (Study Co-ordinator)