Fosfomycin for treating antibiotic-resistant urinary tract infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial aims to evaluate the effectiveness of fosfomycin compared to standard care in children aged 6 months to 18 years with antibiotic-resistant urinary tract infections (UTIs). Participants will be randomly assigned to receive either oral fosfomycin or standard antibiotics based on physician preference. The study will assess the treatment outcomes for both complicated and uncomplicated UTIs, with a focus on reducing hospital admissions and improving patient management. The trial will involve multiple centers and aims to recruit up to 300 participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sydney Childrens Hospital
  Sydney, New South Wales, Australia 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
• The Children's Hospital at Westmead
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Phoebe Williams — University of Sydney
• Study coordinator: Michelle L Harrison
• Email: m.harrison@sydney.edu.au
• Phone: 0411900359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.