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Search / Trial NCT05709028

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

Launched by UNIVERSITY OF SYDNEY · Jan 23, 2023

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medicine called fosfomycin for treating urinary tract infections (UTIs) in children who have infections caused by bacteria that are hard to treat with standard antibiotics. UTIs are common in kids, and sometimes the bacteria causing them do not respond to regular oral antibiotics, which can lead to longer hospital stays. Fosfomycin is an antibiotic that can be taken by mouth, and it's flavored to make it easier for children to take. The trial aims to find out if fosfomycin is just as effective as the usual treatments, whether it is safe for children, and what the best dose would be.

To participate in this trial, children aged 6 months to under 18 years who have symptoms of a UTI and have been tested to confirm they have a specific type of resistant bacteria may be eligible. However, children with certain conditions, such as severe infections or those who cannot take oral medications, cannot join. If your child is part of this study, they will receive either fosfomycin or standard antibiotics and will be monitored for how well the treatment works and whether they have any side effects. This trial is an important step toward finding better, safer treatments for children with difficult-to-treat UTIs.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Sydney

The University of Sydney is a leading research institution in Australia, renowned for its commitment to advancing medical science and improving healthcare outcomes through innovative clinical trials. With a robust infrastructure and a multidisciplinary team of experts, the university fosters a collaborative environment that integrates cutting-edge research with clinical practice. The institution emphasizes ethical standards, patient safety, and scientific rigor in its trials, aiming to translate findings into real-world applications that benefit diverse populations. Through its dedication to excellence and impact, the University of Sydney continues to contribute significantly to the fields of medicine and public health.

Locations

Perth, Western Australia, Australia

Sydney, New South Wales, Australia

Melbourne, Victoria, Australia

Brisbane, Queensland, Australia

Perth, Western Australia, Australia

Sydney, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Phoebe Williams

Principal Investigator

University of Sydney

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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