Condition: Urinary Tract Infections · Sponsor: University of Sydney
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.
Michelle L Harrison · 0411900359 · m.harrison@sydney.edu.au
Always discuss trial participation with your own doctor first.
| Sydney Childrens Hospital | Sydney, New South Wales, Australia | Recruiting |
| The Children's Hospital at Westmead | Sydney, New South Wales, Australia | Not Yet Recruiting |
| Queensland Children's Hospital | Brisbane, Queensland, Australia | Recruiting |
| Royal Childrens Hospital | Melbourne, Victoria, Australia | Recruiting |
| Perth Children's Hospital | Perth, Western Australia, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05709028