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
Co-ordinating PI:
Laila Ibrahim
Study Co-ordinator
Emily McKie
Project aim/s:
The CHOICE UTI study is an international, MRFF-funded RCT across 5 PREDICT sites. The study is asking, for children with complicated UTI presenting to the ED, is a single dose IV plus two days oral as clinically effective as 3 doses IV antibiotics in resolving symptoms at 72 hours?
Definition:
1 dose: one dose of a daily dose IV to cover Gram negative bacteria +/- one dose IV to cover Enterococcus spp. This will be followed by two days oral antibiotics.
3 doses: three doses of a daily dose IV to cover Gram negative bacteria +/- 3 days IV antibiotics to cover Enterococcus spp.
Recruitment:
The Royal Children’s Hospital (Melbourne) commenced recruitment in 2022 and has now recruited 20 patients to the study. In May 2023, both the Women and Children’s Hospital (WCH) (Adelaide) and Monash Medical Centre (Melbourne) commenced recruitment. WCH has now recruited their second patient. Perth Children’s Hospital will be commencing in July 2023 and Starship (New Zealand) is to commence recruitment soon.
Study design:
An open label, multi-centre, pragmatic, non-inferiority randomised controlled trial (RCT). It will incorporate a two-arm, non-inferiority design with parallel groups and 1:1 allocation of children presenting to the ED in whom clinicians deem parenteral antibiotics are required for a febrile complicated UTI.
Current status:
- Royal Children’s Hospital (Melbourne) commenced recruitment in 2022 and has now recruited 25 patients to the study.
- Women and Children’s Hospital (WCH) (Adelaide) commenced recruitment in May 2023 and has recruited 4 patients to the study.
- Monash Medical Centre (Melbourne) commenced recruitment in May 2023 and is waiting to recruit their first patient.
- Perth Children’s Hospital will be commencing recruitment shortly, currently finalising governance sign off.
- Starship (New Zealand) is currently applying for ethics for the study and will commence recruitment soon.