Urinary Tract InfectionsPhase 3FosUTINCT05709028
Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
A Phase 3 study testing Fosfomycin in people with Urinary Tract Infections, run by University of Sydney at 5 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Fosfomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesAustralia
- Study dates
- 2 Aug 2023to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged ≥6 months to <18 years with:
- Symptoms consistent with a clinical diagnosis of a UTI (as per the treating clinician); AND
- 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
- 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
- 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
- The patient has not yet received >48 hours of antibiotics with in vitro activity against the urinary pathogen prior to enrolment.
Who cannot join
- Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR
- Evidence of infection at a secondary site (such as meningitis or endocarditis); OR
- Children with features suggestive of sepsis (defined as requiring inotropic support, or >20ml/kg fluid bolus); OR
- Children who are unable to tolerate or absorb oral antibiotics; OR
- Children with severe renal unsifficiency (creatinine clearance <10ml/minute/1.73m^2); OR
- Known allergy to fosfomycin; OR
- A decision by the primary treating physician that enrolment in the trial is not in the child's best interest.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Queensland Children's Hospital
Brisbane, Queensland, 4101
Adam Irwin, Dr
Adam Irwin
- Recruiting
Royal Childrens Hospital
Melbourne, Victoria, 3052
Amanda Gwee, A/Prof, +61 3 9345 5522, Amanda.Gwee@rch.org.au
Amanda Gwee
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6000
Daniel Yeoh, Dr, +614 2352 0575, daniel.yeoh@health.wa.gov.au
Daniel Yeoh
- Recruiting
Sydney Childrens Hospital
Sydney, New South Wales, 2031
Phoebe Williams, Dr, +61411445575, phoebe.williams1@health.nsw.gov.au
Phoebe Williams
- Not yet recruiting
The Children's Hospital at Westmead
Sydney, New South Wales, 2145
Phillip Britton, A/Prof
Philip Britton
About this study
Official title: Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections: A Non-inferiority, Pragmatic, Multi-centre Adaptive Trial to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral Fosfomycin in Children With Antibiotic-resistant Urinary Tract Infections.
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:
- Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children?
- Is oral fosfomycin a safe and well-tolerated antibiotic in children?
- What is the best dosing regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?
Read the detailed description
This is a Phase 3, non-inferior, pragmatic, multi-centre, adaptive, randomised clinical trial.
Up to 300 participants aged ≥6 months to <18 years of age with a clinical and microbiological diagnosis of an antibiotic-resistant urinary tract infection will be recruited for the trial. Children will be randomised 1:1 to receive either oral fosfomycin (the intervention) or standard of care. The duration of antibiotic treatment will be dependent on whether the child's UTI is complicated or uncomplicated. Children with at least two of the following signs and symptoms will meet criteria of having a complicated UTI: fever, nausea or vomiting, other signs or symptoms of systemic illness: including chilld or rigors, significant fatigue, irritability or malaise above baseline, flank or back pain, ultrasound findings suggestive of an upper renal tract infection, a known history of structural and/or mechanical urological abnormalities, patients with a stent in situ or known renal tract calculi, patients who are immunocompromised. Children who do not meet the criteria for a 'complicated' UTI will meet criteria for an 'uncomplicated' UTI.
For children allocated to the standard of care (S)C) arm: the choice of antibiotic will be as per physician preference based on institutional prescribing practices, local antibiograms and medication availability. Children with an uncomplicated UTI will be prescribed a 3-day course of SOC antibiotics. Then, on Day 3 either; (a) Stop if the child has clinically improved, or (b) Give an additional 48 hours of SOC antibiotics if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or (c) Give an additional 7 days of SOC antibiotics (to make up a total 10-day duration) if the child has evidence of a complicated UTI. Children with a complicated UTI diagnosis at the time of enrolment will be administered a total 10-day course of SOC antibiotics.
For children allocated to the intervention arm: Children with an uncomplicated UTI will be administered a single dose of oral fosfomycin trometamol. Then, on Day 2 either; (a) Stop if the child has clinically improved, or (b) Give an additional dose of oral fosfomycin trometamol if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or (c) Give an additional 8 days of oral fosfomycin trometamol with repeat doses every 48 hours (to make up a total 10-day treatment duration) if the child has evidence of a complicated UTI. Children with a complicated UTI diagnosis at the time of enrolment will be administered a total 10-day course of oral fosfomycin trometamol with repeat doses administered every 48 hours.
Children enrolled into the oral fosfomycin group as well as children enrolled in the standard of care group who receive an oral antibiotic will be asked to complete a tolerability questionnaire following the first dose of the oral antibiotic. The child's parent and a member of their clinical team will also complete this questionnaire. All examinations, investigations and clinical interventions during the study period will be tailored to the child's needs as per routine standard of care. Clinical observations and results will be recorded on a case report form and entered into a secure electronic database. At Day 3, 10 and 28 after enrolment, parents will receive an SMS questionnaire to monitor their ongoing health, capture adverse events and/or capture their medication adherence.
50 children aged ≥6 months to <12 who have been randomised to the fosfomycin arm will be co-enrolled in a pharmacokinetic sub-study. For these children, two blood samples will be taken within 24 hours after the first dose of fosfomycin to determine the plasma fosfomycin concentrations. Co-enrolment into the pharmacokinetic sub-study is optional and will only be performed at a subset of study sites.
- Conditions
- Urinary Tract Infections
- Being tested
- Fosfomycin, Standard of care antibiotics
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosfomycinDrug
Fosfomycin trometamol is a white crystalline powder which is very soluble in water. The granules are mixed with 90ml of cool water for the constitution to dissolve and will be administered soon after reconstitution. Each 30ml will contain 1g fosfomycin base.
- Children ≥ 6 months to <1 year old will be administered 30ml (=1g fosfomycin base) of dissolved solution and the remainder discarded for each dose.
- Children ≥ 1 to 11 years will be administered 60ml (=2g fosfomycin base) of dissolved solution and the remainder discarded for each dose.
- Children ≥12 and <18 years will be administered the entire 90ml solution (= 3g fosfomycin base) for each dose.
Standard of care antibioticsDrug
Standard of care antibiotics will be chosen by the treating clinician according to institutional prescribing practices, local antibiograms and medication availability.
| Study group | Role | What they receive |
|---|---|---|
| Oral fosfomycin | Experimental | * Children who have been diagnosed with an uncomplicated UTI will be administered a single dose of oral fosfomycin trometamol. Then, on Day 2 either;
1. Stop if the child has clinically improved, or
2. Give a second dose of oral fosfomycin trometamol if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or
3. Give an additional 8 days of oral fosfomycin trometamol with repeat doses every 48 hours (to make up a total 10-day treatment duration) if the child has evidence of a complicated UTI.
* Children who have been diagnosed with a complicated UTI will be administered repeat doses of oral fosfomycin trometamol every 48 hours until the child has received a total 10-day course of antibiotics with presumed or proven efficacy against the urinary pathogen. Receives: Drug: Fosfomycin |
| Standard of Care antibiotics | Active comparator | * Children who have been diagnosed with an uncomplicated UTI will be administered a 3-day course of standard of care (SOC) antibiotics with known efficacy against the urinary pathogen. Then, on Day 3 either;
1. Stop of the child has clinically improved, or
2. Give an additional 48 hours of SOC antibiotics if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or
3. Give an additional 7 days of SOC antibiotics (to make up a total 10-day duration) if the child has evidence of a complicated UTI.
* Children who have been diagnosed with a complicated UTI will be administered a total 10-day course of SOC antibiotics with known efficacy against the urinary pathogen. Receives: Drug: Standard of care antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure within 28 days after enrolment between patients treated with standard of care versus oral fosfomycin.
Treatment failure is defined as:
- Persistent or recurrent (clinical and microbiologically-confirmed) diagnosis of a UTI between 7 and 28 days after enrolment, with the same uropathogen; or
- Decision to switch to an alternative antibiotic due to perceived treatment failure; or
- Isolation of the same pathogenic organism from a new sterile site between 7 and 28 days after enrolment;
Measured: 28 days
Secondary outcomes (5)
Occurrence of treatment-related adverse events to Day 28
Measured: 28 days
Occurrence of serious adverse events attributable to UTI to Day 28
Measured: 28 days
Evidence of primary treatment failure, defined as: a) Persistent fever (>38.0C) attributable to UTI at 72h after enrolment; and/or b) Failure to return to baseline health at 28 days after enrolment
Measured: 28 days
Evaluation of the cost of hospital resources in the first 28 days of enrolment in children receiving standard of care versus oral fosfomycin; including: a) Cost of prescribed drugs b) Cost of hospital services (inpatient and outpatient)
Measured: 28 days
Assessment of the tolerability of oral antibiotic therapy in children, using a 5-point facial hedonic scale immediately after the first oral dose
To assess the tolerability of oral fosfomycin, children ≥3 years will be asked immediately after administration of their first dose of fosfomycin or alternative oral antibiotic (if prescribed within SOC), to record how much he or she liked the sample by putting a mark on a 5-point facial hedonic scale (ranging from 1, dislike very much; to 5, liked very much); and whether they would be happy to take the medication again if required. The parent and treating nurse or doctor will also be asked independently to give a score, using separate 5-point hedonic scales, based on their perception of how the child reacted to the taste of oral fosfomycin or alternative oral antibiotic.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start2 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial with an intervention arm and an active control arm (standard-of care)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phoebe Williams, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709028
- Sponsor's protocol ID
- FosUTI
- Acronym
- FosUTI
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Efficacy and AEs/SAEs will be summarised and pooled. Deidentified individual data will be shared with the DSMB and ethics for SAEs only. Investigators have the protocols and the ICFs. SAP will be available for all investigators once authored. Reports and analytical code will be shared when approved by trial statisticians.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections: A Non-inferiority, Pragmatic, Multi-centre Adaptive Trial to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral Fosfomycin in Children With Antibiotic-resistant Urinary Tract Infections.
- ClinicalTrials.gov ID
- NCT05709028
- Acronym / sponsor ID
- FosUTI / FosUTI
- Conditions
- Urinary Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children?
- Is oral fosfomycin a safe and well-tolerated antibiotic in children?
- What is the best dosing regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?
Detailed description
This is a Phase 3, non-inferior, pragmatic, multi-centre, adaptive, randomised clinical trial.
Up to 300 participants aged ≥6 months to <18 years of age with a clinical and microbiological diagnosis of an antibiotic-resistant urinary tract infection will be recruited for the trial. Children will be randomised 1:1 to receive either oral fosfomycin (the intervention) or standard of care. The duration of antibiotic treatment will be dependent on whether the child's UTI is complicated or uncomplicated. Children with at least two of the following signs and symptoms will meet criteria of having a complicated UTI: fever, nausea or vomiting, other signs or symptoms of systemic illness: including chilld or rigors, significant fatigue, irritability or malaise above baseline, flank or back pain, ultrasound findings suggestive of an upper renal tract infection, a known history of structural and/or mechanical urological abnormalities, patients with a stent in situ or known renal tract calculi, patients who are immunocompromised. Children who do not meet the criteria for a 'complicated' UTI will meet criteria for an 'uncomplicated' UTI.
For children allocated to the standard of care (S)C) arm: the choice of antibiotic will be as per physician preference based on institutional prescribing practices, local antibiograms and medication availability. Children with an uncomplicated UTI will be prescribed a 3-day course of SOC antibiotics. Then, on Day 3 either; (a) Stop if the child has clinically improved, or (b) Give an additional 48 hours of SOC antibiotics if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or (c) Give an additional 7 days of SOC antibiotics (to make up a total 10-day duration) if the child has evidence of a complicated UTI. Children with a complicated UTI diagnosis at the time of enrolment will be administered a total 10-day course of SOC antibiotics.
For children allocated to the intervention arm: Children with an uncomplicated UTI will be administered a single dose of oral fosfomycin trometamol. Then, on Day 2 either; (a) Stop if the child has clinically improved, or (b) Give an additional dose of oral fosfomycin trometamol if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or (c) Give an additional 8 days of oral fosfomycin trometamol with repeat doses every 48 hours (to make up a total 10-day treatment duration) if the child has evidence of a complicated UTI. Children with a complicated UTI diagnosis at the time of enrolment will be administered a total 10-day course of oral fosfomycin trometamol with repeat doses administered every 48 hours.
Children enrolled into the oral fosfomycin group as well as children enrolled in the standard of care group who receive an oral antibiotic will be asked to complete a tolerability questionnaire following the first dose of the oral antibiotic. The child's parent and a member of their clinical team will also complete this questionnaire. All examinations, investigations and clinical interventions during the study period will be tailored to the child's needs as per routine standard of care. Clinical observations and results will be recorded on a case report form and entered into a secure electronic database. At Day 3, 10 and 28 after enrolment, parents will receive an SMS questionnaire to monitor their ongoing health, capture adverse events and/or capture their medication adherence.
50 children aged ≥6 months to <12 who have been randomised to the fosfomycin arm will be co-enrolled in a pharmacokinetic sub-study. For these children, two blood samples will be taken within 24 hours after the first dose of fosfomycin to determine the plasma fosfomycin concentrations. Co-enrolment into the pharmacokinetic sub-study is optional and will only be performed at a subset of study sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial with an intervention arm and an active control arm (standard-of care)
| Arm | Type | Receives |
|---|---|---|
| Oral fosfomycin | Experimental | Drug: Fosfomycin* Children who have been diagnosed with an uncomplicated UTI will be administered a single dose of oral fosfomycin trometamol. Then, on Day 2 either; 1. Stop if the child has clinically improved, or 2. Give a second dose of oral fosfomycin trometamol if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or 3. Give an additional 8 days of oral fosfomycin trometamol with repeat doses every 48 hours (to make up a total 10-day treatment duration) if the child has evidence of a complicated UTI. * Children who have been diagnosed with a complicated UTI will be administered repeat doses of oral fosfomycin trometamol every 48 hours until the child has received a total 10-day course of antibiotics with presumed or proven efficacy against the urinary pathogen. |
| Standard of Care antibiotics | Active comparator | Drug: Standard of care antibiotics* Children who have been diagnosed with an uncomplicated UTI will be administered a 3-day course of standard of care (SOC) antibiotics with known efficacy against the urinary pathogen. Then, on Day 3 either; 1. Stop of the child has clinically improved, or 2. Give an additional 48 hours of SOC antibiotics if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or 3. Give an additional 7 days of SOC antibiotics (to make up a total 10-day duration) if the child has evidence of a complicated UTI. * Children who have been diagnosed with a complicated UTI will be administered a total 10-day course of SOC antibiotics with known efficacy against the urinary pathogen. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Symptoms consistent with a clinical diagnosis of a UTI (as per the treating clinician); AND
- 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
- 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
- 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
- The patient has not yet received >48 hours of antibiotics with in vitro activity against the urinary pathogen prior to enrolment.
Key exclusion criteria (7 listed)
- Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR
- Evidence of infection at a secondary site (such as meningitis or endocarditis); OR
- Children with features suggestive of sepsis (defined as requiring inotropic support, or >20ml/kg fluid bolus); OR
- Children who are unable to tolerate or absorb oral antibiotics; OR
- Children with severe renal unsifficiency (creatinine clearance <10ml/minute/1.73m^2); OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FosfomycinFosfomycin trometamol is a white crystalline powder which is very soluble in water. The granules are mixed with 90ml of cool water for the constitution to dissolve and will be administered soon after reconstitution. Each 30ml will contain 1g fosfomycin base. * Children ≥ 6 months to <1 year old will be administered 30ml (=1g fosfomycin base) of dissolved solution and the remainder discarded for each dose. * Children ≥ 1 to 11 years will be administered 60ml (=2g fosfomycin base) of dissolved solution and the remainder discarded for each dose. * Children ≥12 and <18 years will be administered the entire 90ml solution (= 3g fosfomycin base) for each dose. | Drug | Oral fosfomycin |
| Standard of care antibioticsStandard of care antibiotics will be chosen by the treating clinician according to institutional prescribing practices, local antibiograms and medication availability. | Drug | Standard of Care antibiotics |
Primary outcome
Treatment failure within 28 days after enrolment between patients treated with standard of care versus oral fosfomycin.
Time frame: 28 days
Treatment failure is defined as: 1. Persistent or recurrent (clinical and microbiologically-confirmed) diagnosis of a UTI between 7 and 28 days after enrolment, with the same uropathogen; or 2. Decision to switch to an alternative antibiotic due to perceived treatment failure; or 3. Isolation of the same pathogenic organism from a new sterile site between 7 and 28 days after enrolment;
5 secondary outcomes
Occurrence of treatment-related adverse events to Day 28
Time frame: 28 days
Occurrence of serious adverse events attributable to UTI to Day 28
Time frame: 28 days
Evidence of primary treatment failure, defined as: a) Persistent fever (>38.0C) attributable to UTI at 72h after enrolment; and/or b) Failure to return to baseline health at 28 days after enrolment
Time frame: 28 days
Evaluation of the cost of hospital resources in the first 28 days of enrolment in children receiving standard of care versus oral fosfomycin; including: a) Cost of prescribed drugs b) Cost of hospital services (inpatient and outpatient)
Time frame: 28 days
Assessment of the tolerability of oral antibiotic therapy in children, using a 5-point facial hedonic scale immediately after the first oral dose
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No. Efficacy and AEs/SAEs will be summarised and pooled. Deidentified individual data will be shared with the DSMB and ethics for SAEs only. Investigators have the protocols and the ICFs. SAP will be available for all investigators once authored. Reports and analytical code will be shared when approved by trial statisticians.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phoebe Williams principal investigator
University of Sydney
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosfomycin in people with Urinary Tract Infections, run by University of Sydney at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle L Harrison (0411900359, m.harrison@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure within 28 days after enrolment between patients treated with standard of care versus oral fosfomycin. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.