Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
Recruiting
Phase 3
Interventional Study
Urinary Tract Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- University of Sydney · Other
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About This Trial
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 manage…
Trial Locations
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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 ≥1…
Contacts