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

Study acronym: FosUTI
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 6 to 5
    • Study description expanded, about 120 words
    • Site details revised at 2 of 5 sites
    v6
  2. Primary endpoint revisedv5 Show 5 more changesShow less
    • Interventions: Fosfomycin 3000 MG [Monurol] (Drug), Standard of care (Other) to Fosfomycin (Drug), Standard of care antibiotics (Drug)
    • Secondary endpoints: 1 to 6
    • Study description expanded, about 488 words
    • Site contacts updated at 5 of 5 sites
    • Eligibility criteria expanded, about 4 words
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary and study completion dates: Feb 2026 to Aug 2027
    • Start date changed from estimate of Apr 2023 to Aug 2, 2023
    • Study sites: 3 to 5
    • Eligibility criteria expanded, about 37 words
  4. Start date: Feb 2023 to Apr 2023v3
  5. Start date: Jan 2023 to Feb 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?
Trial Details
NCT Number NCT05709028
Lead Sponsor University of Sydney
Conditions
(from sponsor)		 Urinary Tract Infections
Related terms Urinary Tract Infections
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov