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

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this clinical trial is to determine, in children with multi-drug resistant urinary tract infections, whether oral fosfomycin is noninferior to standard of care antibiotics in achieving a cure without recurrence within 30 days of treatment. The

The main questions the trial aims to answer are:

1. Is oral fosfomycin inferior in efficacy to the current standard to care for multi-drug resistant UTIs in children as defined by the recurrence of a UTI within 30 days of completion of therapy?

2. Is fosfomycin a safe and well-tolerated antibiotic in children?

Participants aged ≥1 to <18 years of age with a clinical diagnosis of antibiotic-resistant urinary tract infections will be recruited and randomised after informed consent is obtained via computer generated randomisation into standard of care or intervention (treatment with oral fosfomycin) arms.

For children randomised into the standard of care arm: Management will be as per physician preference based on institutional prescribing practices and local antibograms.

For children randomised into the intervention arm: a single dose of oral fosfomycin trometamol will be prescribed (with dosage determined based on age).

Both groups will complete a tolerability questionnaire and be subject to physical examination, pathology investigations and other clinical interventions tailored to their needs as per routine standard of care. Clinical observations and results of the investigation will be recorded on a case report form via an electronic database. A follow-up safety review will be performed 10 and 28 days after enrollment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Treatments: Fosfomycin

Criteria

Inclusion Criteria:

Children aged ≥1 to <18 years with:

1. Symptoms suggestive of a clinical diagnosis of a UTI (as per the treating clinician); AND

2. Microbiological confirmation: Defined as a urine culture revealing pure growth of a single bacterial uropathogen [≥106 CFU/L, or ≥103 CFU/mL] together with ≥10 white blood cells [WBCs] per high power field in centrifuged urine on microscopy, or ≥10 WBCs/mm3 in uncentrifuged urine]; AND

3. The bacterial uropathogen is one of: Escherichia coli, Proteus spp., Klebsiella spp., Enterobacter spp., Serratia spp., or Citrobacter spp., AND

4. The uropathogen has evidence of resistance to all oral penicillins and cephalosporins AND

5. The patient has not yet received ≥48 hours of antibiotics effective against the urinary pathogen prior to enrolment.

Exclusion Criteria:

1. Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR

2. Evidence of infection at a secondary site (such as CNS infection or endocarditis); OR

3. Children with features suggestive of sepsis (defined as requiring inotropic support, or >20ml/kg fluid bolus); OR

4. Children who are unable to tolerate or absorb oral antibiotics; OR

5. Creatinine clearance <40ml/minute; OR

6. Known allergy to fosfomycin.