← Eichor
Study identifier: NCT05709028 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections

Condition: Urinary Tract Infections  ·  Sponsor: University of Sydney

PhasePhase 3
Planned participants300
Who can joinAll sexes, 6 Months to 17 Years
Healthy volunteersNo

About this study

Urinary tract infections (UTIs) are among the most common bacterial infections in children. Up to 50% of UTI's are caused by multi-drug resistant ESBL-producing gram negative bacteria that do not respond to treatment with oral penicillin's or cephalosporins. Instead, children often require hospital admission to receive broad-spectrum intravenous antibiotics when they may otherwise be safely managed at home; resulting in prolonged hospital stays and an increased use of health resources. Fosfomycin is a broad-spectrum antibiotic discovered in 1969 that remains susceptible to a large number of organisms due to its low international use. Fosfomycin can be prepared as an oral solution with an orange/tangerine flavour and is currently approved for use in females \>12 years old. Despite extensive evidence of its efficacy in adults and safety in neonates, the use of fosfomycin in children remains limited and fosfomycin is not currently licensed for use in children \<12 years old in Australia. The aim of this clinical trial is to compare the use of oral fosfomycin against standard of care antibiotics for the treatment of antibiotic resistant urinary tract infections in children. The main questions the trial aims to answer are: 1. Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children? 2. Is oral fosfomycin a safe and well-tolerated antibiotic in children? 3. What is the best dosing re…

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

Talk to the study team

Michelle L Harrison  ·  0411900359  ·  m.harrison@sydney.edu.au

Always discuss trial participation with your own doctor first.

Locations (5)

Sydney Childrens HospitalSydney, New South Wales, AustraliaRecruiting
The Children's Hospital at WestmeadSydney, New South Wales, AustraliaNot Yet Recruiting
Queensland Children's HospitalBrisbane, Queensland, AustraliaRecruiting
Royal Childrens HospitalMelbourne, Victoria, AustraliaRecruiting
Perth Children's HospitalPerth, Western Australia, AustraliaRecruiting

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/NCT05709028