Actively Recruiting
Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
Led by University of Sydney · Updated on 2024-06-06
300
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 managed at home; resulting in prolonged hospital stays and an increased use of health resources. Fosfomycin is a broad-spectrum antibiotic discovered in 1969 that remains susceptible to a large number of organisms due to its low international use. Fosfomycin can be prepared as an oral solution with an orange/tangerine flavour and is currently approved for use in females \>12 years old. Despite extensive evidence of its efficacy in adults and safety in neonates, the use of fosfomycin in children remains limited and fosfomycin is not currently licensed for use in children \<12 years old in Australia. The aim of this clinical trial is to compare the use of oral fosfomycin against standard of care antibiotics for the treatment of antibiotic resistant urinary tract infections in children. The main questions the trial aims to answer are: 1. Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children? 2. Is oral fosfomycin a safe and well-tolerated antibiotic in children? 3. What is the best dosing regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?
CONDITIONS
Official Title
Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to under 18 years
- Symptoms consistent with a clinical diagnosis of urinary tract infection
- Urine culture showing predominant growth of a bacterial uropathogen (≥10^6 CFU/L or ≥10^3 CFU/mL) with ≥10x10^6 white blood cells on microscopy
- Bacterial pathogen is a non-pseudomonal gram-negative organism commonly causing UTIs in children (Escherichia coli, Proteus spp., Klebsiella spp., Enterobacter spp., Serratia spp., or Citrobacter spp.)
- Pathogen shows resistance to all oral penicillins and oral first- and second-generation cephalosporins or presumed resistance based on testing
- Patient has received less than 48 hours of antibiotics active against the urinary pathogen before enrollment
You will not qualify if you...
- Evidence of bacteraemia due to the same urinary pathogen in the current illness
- Infection at a secondary site such as meningitis or endocarditis
- Signs of sepsis requiring inotropic support or more than 20ml/kg fluid bolus
- Inability to tolerate or absorb oral antibiotics
- Severe renal insufficiency with creatinine clearance under 10ml/min/1.73m²
- Known allergy to fosfomycin
- Physician decision that trial enrollment is not in the child's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Sydney Childrens Hospital
Sydney, New South Wales, Australia, 2031
Actively Recruiting
2
The Children's Hospital at Westmead
Sydney, New South Wales, Australia, 2145
Not Yet Recruiting
3
Queensland Children's Hospital
Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Royal Childrens Hospital
Melbourne, Victoria, Australia, 3052
Actively Recruiting
5
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
Research Team
M
Michelle L Harrison
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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