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

RecruitingPhase 3Ages 6 Months - 17 YearsAllUniversity of Sydney
NCT05709028 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 remain

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📋 Eligibility rules (as published)
Inclusion Criteria: Children aged ≥6 months to \<18 years with: 1. Symptoms consistent with a clinical diagnosis of a UTI (as per the treating clinician); AND 2. Microbiological confirmation: Defined as a urine culture revealing a predominant growth of a bacterial uropathogen \[≥10\^6 CFU/L, or ≥10\^3 CFU/mL\] together with ≥10x10\^6 white blood cells on microscopy; AND 3. The bacterial uropathogen is a non-pseudomonal gram-negative organism likely to cause urinary tract infections in children; being one of either: Escherichia coli, Proteus spp., Klebsiella spp., Enterobacter spp., Serratia spp., or Citrobacter spp., AND 4. The uropathogen has in vitro evidence of resistance to all oral penicillins and oral first- and second- generation cephalosporins (or is presumed to be resistant based on the pattern of phenotypic testing); AND 5. The patient has not yet received \>48 hours of antibiotics with in vitro activity against the urinary pathogen prior to enrolment. Exclusion Criteria: 6. Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR 7. Evidence of infection at a secondary site (such as meningitis or endocarditis); OR 8. Children with features suggestive of sepsis (defined as requiring inotropic support, or \>20ml/kg fluid bolus); OR 9. Children who are unable to tolerate or absorb oral antibiotics; OR 10. Children with severe renal unsifficiency (creatinine clearance \<10ml/minute/1.73m\^2); OR 11. Known allergy to fosfomycin; OR 12. A decision by the primary treating physician that enrolment in the trial is not in the child's best interest.
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What it tests

  • Fosfomycin
  • Standard of care antibiotics
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Where

5 sites
Sydney Childrens Hospital
Sydney, Australia
The Children's Hospital at Westmead
Sydney, Australia
Queensland Children's Hospital
Brisbane, Australia
Royal Childrens Hospital
Melbourne, Australia
Perth Children's Hospital
Perth, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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