← Eichor
Study identifier: NCT04876131 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Condition: Complicated Urinary Tract Infection · Infection · Pediatric Infectious Disease  ·  Sponsor: Murdoch Childrens Research Institute

PhasePhase 4
Planned participants452
Who can joinAll sexes, 3 Months to 18 Years
Healthy volunteersNo

About this study

Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes. This multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive…

This description comes directly from the study's public registry record.

Talk to the study team

Laila Ibrahim  ·  +61401765546  ·  laila.ibrahim@mcri.edu.au

Lucy Hill  ·  +61383416200  ·  lucy.hill@mcri.edu.au

Always discuss trial participation with your own doctor first.

Locations (7)

Flinders Medical CentreAdelaide, South Australia, AustraliaRecruiting
Women and Children's HospitalAdelaide, South Australia, AustraliaRecruiting
University Hospital GeelongGeelong, Victoria, AustraliaRecruiting
Monash HealthMelbourne, Victoria, AustraliaRecruiting
Royal Children's HospitalParkville, Victoria, AustraliaRecruiting
Perth Children's HospitalPerth, Washington, AustraliaRecruiting
Starship Children's HospitalAuckland, Auckland Province, New ZealandRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT04876131