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:
Participant gender:
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.