Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05137119




Registration number
NCT05137119
Ethics application status
Date submitted
25/04/2021
Date registered
30/11/2021
Date last updated
5/06/2024

Titles & IDs
Public title
Staphylococcus Aureus Network Adaptive Platform Trial
Scientific title
Staphylococcus Aureus Network Adaptive Platform Trial
Secondary ID [1] 0 0
CT19029
Universal Trial Number (UTN)
Trial acronym
SNAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcus Aureus Bacteremia 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cefazolin
Treatment: Drugs - Penicillin
Treatment: Drugs - Clindamycin
Treatment: Drugs - Vancomycin
Other interventions - Effectiveness of early switch to oral antibiotics
Treatment: Other - Whole body FDG PET/CT Imaging

No intervention: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy) - Vancomycin or Daptomycin - Standard Therapy Arm

Either intravenous vancomycin dosed as per Australian Therapeutic Guidelines: This includes a loading dose of 25 mg/kg (up to 3000mg) if considered appropriate by the treating clinician, initial maintenance dosing at 15-20 mg/kg q12h, with subsequent adjustment to maintain area under the concentration-time curve (AUC) of 400 to 600 mg.hr/L OR trough levels at 10-20 mg/L, and the initial level taken 48-72 hours after the initiation of the first dose. Daptomycin 8-10mg/kg per day intravenously. The choice of vancomycin or daptomycin will be at the clinician's discretion. Dosing will be based on renal function.

Experimental: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy) - Vancomycin or Daptomycin (Standard Therapy) + Beta-Lactam (ß-lactam) Arm

In addition to standard treatment an intravenous ß-lactam will be added for the first 7 calendar days following randomisation (day 1 being the day of randomisation - hence patients will receive 6-7 days of ß-lactam). This ß-lactam will be intravenous cefazolin 2g every 8 hours. For patients with renal impairment the intravenous cefazolin administration doses will be adjusted.

No intervention: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy) - Flucloxacillin or cloxacillin - Standard Therapy Arm

Either intravenous flucloxacillin/cloxacillin 2g every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous flucloxacillin administration dose will be adjusted.

Experimental: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy) - Cefazolin - Interventional Arm

Intravenous cefazolin 2g every 6 or 8 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous cefazolin administration dose will be adjusted.

No intervention: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy) - Flucloxacillin or cloxacillin - Standard Therapy Arm

Either intravenous flucloxacillin/cloxacillin 2g every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with renal impairment or critical illness the intravenous flucloxacillin administration dose will be adjusted.

Experimental: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy) - Benzylpenicillin - Interventional Arm

Intravenous benzylpenicillin 1.8g (3 million units) every 4 or 6 hours. The minimum protocol duration of allocated study treatment is 14 days for those not allocated to early oral switch, and 5 days for those allocated to early oral switch. For patients with critical illness the intravenous benzylpenicillin administration doses will be adjusted.

No intervention: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm - No adjunctive therapy + backbone therapy arm for MRSA or MSSA or PSSA

Participants with either MRSA or MSSA or PSSA will have no adjunctive therapy in combination with their backbone therapy arm.

Experimental: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy arm - Adjunctive therapy + backbone therapy arm for MRSA or MSSA or PSSA Intravenous clindamycin (or lincomycin) 600mg every 8 hours from platform day 1 to day 5. No dosage adjustment is needed to renal impairment.

No intervention: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care arm - Backbone therapy arm for MRSA or MSSA or PSSA +/- adjunctive therapy will continue on intravenous antibiotic treatment for the length of time as per usual standard of care.

Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised if not eligible then eligibility will be assess again at Day 14(+/- 2 days). If eligibility is not met at day 14 then participant is excluded from this domain.

Experimental: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible. - Switch from intravenous backbone antibiotic for MRSA or MSSA or PSSA to oral antibiotics at the treating clinicians discretion on trial Day 7 (+/- 2 days) or trial Day 14 (+/- 2 days).

Participants eligibility is assessed at Day 7 (+/- 2 days). If eligible will be randomised, if not eligible then eligibility will be assessed again at Day 14 (+/- 2 days). If eligibility is not met at day 14 then participant is excluded from this domain.

No intervention: No PET/CT scan - standard of care arm - Participants will not receive a PET/CT scan, in addition to their allocated treatment interventions.

Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised. If eligibility is not met then participant is excluded from this domain.

Experimental: PET/CT scan at trial day 7 (+/- 2 days) if eligible - Participant will receive a PET/CT scan at Day 5-12, in addition to their allocated treatment interventions.

Participants eligibility is assessed at Day 7 (+/- 2 days) if eligible will be randomised. If eligibility is not met then participant is excluded from this domain.


Treatment: Drugs: Cefazolin
Cefazolin

Treatment: Drugs: Penicillin
benzylpenicillin

Treatment: Drugs: Clindamycin
Clindamycin

Treatment: Drugs: Vancomycin
Vancomycin or Daptomycin

Other interventions: Effectiveness of early switch to oral antibiotics
This involves testing a strategy rather than individual antibiotic agents

Treatment: Other: Whole body FDG PET/CT Imaging
Whole body FDG PET/CT imaging will be performed using a standardised protocol describing patient preparation and minimum specifications for radiopharmaceutical production, quality control, and PET/CT acquisition.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality at 90 days after platform entry
Timepoint [1] 0 0
From randomisation (day 1) until day 90
Secondary outcome [1] 0 0
All-cause mortality at 14, 28 and 42 days after platform entry
Timepoint [1] 0 0
From randomisation (day 1) until day 14, 28, and 42
Secondary outcome [2] 0 0
Duration of survival censored at 90 days after platform entry
Timepoint [2] 0 0
From randomisation (day 1) until day 90
Secondary outcome [3] 0 0
Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab).
Timepoint [3] 0 0
From randomisation (day 1) until discharge from acute inpatient facilities, truncated at 90 days.
Secondary outcome [4] 0 0
Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab)
Timepoint [4] 0 0
From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days
Secondary outcome [5] 0 0
Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry
Timepoint [5] 0 0
From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days
Secondary outcome [6] 0 0
Microbiological treatment failure defined as positive sterile site culture for S. aureus [of the same silo as the index isolate between 14 and 90 days after platform entry).
Timepoint [6] 0 0
From randomisation (day 1) until day 90
Secondary outcome [7] 0 0
Diagnosis of new foci between 14 and 90 days after platform entry.
Timepoint [7] 0 0
From randomisation (day 1) until day 90
Secondary outcome [8] 0 0
C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants =2 years of age.
Timepoint [8] 0 0
From randomisation (day 1) until day 90
Secondary outcome [9] 0 0
Number of participants with Serious adverse reactions (SARs) in the 90 days following platform entry
Timepoint [9] 0 0
From randomisation (day 1) until day 90
Secondary outcome [10] 0 0
Health economic costs as detailed in the cost utility analysis appendix.
Timepoint [10] 0 0
From randomisation (day 1) until day 90
Secondary outcome [11] 0 0
Proportion of participants who have returned to their usual level of function at day 90.
Timepoint [11] 0 0
From randomisation (day 1) until day 90
Secondary outcome [12] 0 0
Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version)
Timepoint [12] 0 0
From randomisation (day 1) until day 90
Secondary outcome [13] 0 0
Desirability of outcome ranking 2 (SNAP version)
Timepoint [13] 0 0
From randomisation (day 1) until day 90
Secondary outcome [14] 0 0
Number of antibiotic days (IV and/or oral/enteral)
Timepoint [14] 0 0
From randomisation (day 1) until day 90
Secondary outcome [15] 0 0
Days alive and free of antibiotics
Timepoint [15] 0 0
From randomisation (day 1) until day 90

Eligibility
Key inclusion criteria
PLATFORM

Patients must fulfil all of the following criteria to be eligible to enter the SNAP trial:

1. Staphylococcus aureus complex grown from =1 blood culture
2. Admitted to a participating hospital at the time of eligibility assessment

PLATFORM
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the trial:

1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture. Where the time of culture collection is not recorded, the time of laboratory registration of the sample will be used as an alternative
2. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform eligibility assessment, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician.
3. Known previous participation in the randomised SNAP platform
4. Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment
5. Treating team deems enrolment in the study is not in the best interest of the patient
6. Treating team believes that death is imminent and inevitable
7. Patient is for end-of-life care and antibiotic treatment is considered not appropriate
8. Patient <18 years of age and paediatric recruitment not approved at recruiting site
9. Patient has died since the collection of the index blood culture

To be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above)

ADJUNCTIVE TREATMENT DOMAIN

Inclusion Criteria:

1. All participants that met the PLATFORM eligible are eligible to be included in this domain unless they meet any of the following exclusions listed.
2. Patients are eligible for this domain regardless of S. aureus susceptibility testing results to clindamycin.

Exclusion criteria:

1. Previous type 1 hypersensitivity reaction to lincosamides 2. Currently receiving clindamycin (lincomycin) or linezolid which cannot be ceased or substituted 3. Necrotising fasciitis 4. Current C. difficile associated diarrhoea (any severity) 5. Current severe diarrhoea from any cause (defined as Grade 3 or higher) 5. Known CDAD (C.Difficile Associated Diarrhoea) in the past 3 months, or CDAD relapse in the past 12 months 6. At the time of domain eligibility assessment, more than 4 hours has elapsed since platform entry 7. Treating clinician deems enrolment in this domain is not in the best interest of the patient

PSSA, MSSA TREATMENT DOMAIN (backbone)

Inclusion Criteria:

1. For PSSA silo: Index blood culture is penicillin-susceptible as per phenotypic disc testing with EUCAST (a P1 disc diffusion with a feathered zone >=26mm) OR CLSI (a P10 disc diffusion) defined criteria
2. For MSSA silo: Index blood culture isolate is methicillin-susceptible but penicillin resistant

Exclusion Criteria (PSSA & MSSA):

1. >72 hours have elapsed since the collection of the index blood culture (i.e. the time of collection of the first positive blood culture from the patient during this episode)
2. History of type I hypersensitivity reaction (i.e. anaphylaxis or angioedema) to any penicillin or cephalosporin
3. History of severe delayed reaction (e.g. allergic interstitial nephritis, cutaneous vasculitis, Stevens-Johnson, DRESS, etc.) to any penicillin or cephalosporin
4. PSSA silo: Non-severe rash to any penicillin (unless patient has been subsequently de-labelled; this criteria does not include criteria 2 and 3 above), or MSSA silo: Non-severe rash to cefazolin or any penicillin (unless patient has been subsequently de-labelled) (Nausea, diarrhoea, headache, and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)
5. Treating team deems enrolment in this domain is not in the best interest of the patient
6. Currently receiving maintenance dialysis (haemodialysis or peritoneal dialysis) (Acute renal replacement therapy (including CRRT, haemodialysis or peritoneal dialysis) are not exclusions. Such patients are eligible as long as appropriate vascular access is available or can be arranged.)
7. Polymicrobial bacteraemia (defined as more than one organism [at species level] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment
8. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)

MRSA TREATMENT DOMAIN (backbone)

Inclusion Criteria:

1. MRSA confirmed microbiologically



1. Time to allocation reveal is >72 hours from time of index blood culture collection
2. Severe allergy to any beta-lactam (including cefazolin) Immediate severe allergy: Anaphylaxis/angioedema Severe delayed allergy: Severe cutaneous adverse reaction (SCAR; including Steven Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)), severe drug induced liver injury, proven allergic interstitial nephritis, immune-mediated haemolytic anaemia and other severe cytopenia.
3. Non-severe rash to cefazolin Nausea, diarrhoea, headache and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)

3. Severe allergy or non-severe rash to both vancomycin AND daptomycin Vancomycin infusion reaction (formerly known as "red man syndrome") is due to direct histamine release and is not generally an allergy, and therefore is not considered an exclusion.

5. Treating team deems enrolment in the domain is not in the best interest of the patient 6. Polymicrobial bacteraemia (defined as more than one organism [at species level] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment.

7. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)

EARLY ORAL SWITCH DOMAIN

Inclusion Criteria:

Day 7 (+/- 2 days):

1. Clearance of SAB by platform Day 2: blood cultures negative for S. aureus from platform Day 2 onwards AND no known subsequent positive blood cultures
2. Afebrile (<37.8°C) for the past 72 hours (at time of judging eligibility)
3. Primary focus is either line related (either central or peripheral IV cannula) or skin and soft tissue, AND source control achieved (for 'line-related' this means line removed; for 'skin and soft tissue' means site PI considers source control to have been achieved and any abscess more than 2cm diameter has been drained)
4. No evidence of metastatic foci (on clinical or radiological examination, but radiological imaging is not required to exclude metastatic foci if not clinically indicated)

Day 14 (+/- 2 days):

1. Clearance of SAB by platform Day 5: blood cultures negative for S. aureus from platform Day 5 (+/-1 day) AND no known subsequent positive blood cultures. If the most recent blood culture from Day 2-4 is negative for S. aureus, blood cultures do not need to be repeated on Day 5 to fulfil eligibility criteria (Day 5 blood cultures will be assumed to be negative in this situation)
2. Afebrile (<37.8°C) for the past 72 hours (at time of judging eligibility)
3. Site Principal Investigator has determined that source control is adequate



When judging eligibility at platform Day 7 (+/- 2 days) and at Day 14 (+/- 2 days), exclusion criteria are:

1. Adherence to oral agents unlikely (as judged by site PI in consultation with the treating team)
2. Unreliable gastrointestinal absorption (e.g. vomiting, diarrhoea, nil by mouth, anatomical reasons)
3. There are no appropriate oral antibiotics due to contraindications, drug availability, or antibiotic resistance
4. Ongoing IV therapy unsuitable e.g. no IV access
5. Clinician deems not appropriate for early oral switch
6. Patient no longer willing to participate in domain In the lead-up to judging eligibility, it may be helpful to discuss with the patient the potential for continued IV treatment versus oral switch, to allow hospital discharge planning
7. Clinical team deems that sufficient duration of antibiotic therapy has already been provided

Exclusions when judging eligibility for early oral switch at trial Day 7 (+/- 2 days):

1. Presence of prosthetic cardiac valve, pacemaker or other intracardiac implant
2. Presence of intravascular clot, graft, or other intravascular prosthetic material Intravascular clot excludes superficial peripheral IV line-related thrombophlebitis. Intravascular prosthetic material excludes coronary artery stents)
3. Intravascular/intracardiac infections (e.g. endocarditis, mycotic aneurysm)
4. Presence of other intracardiac abnormalities felt to put patient at increased risk of endocarditis (e.g., bicuspid aortic valve)

PET/CT DOMAIN

Inclusion Criteria:

1. PET/CT participating site
2. Patient is accessible for PET/CT - a patient is considered accessible if the site team are able to access the participant medical records, arrange for a PET/CT scan for the patient, and discuss this domain with the patient and their treating healthcare providers.



1. Pregnant - patients of childbearing potential should be assessed for pregnancy status and a pregnancy test performed (if not performed within the past 10 days)
2. Currently breastfeeding
3. < 18 years of age
4. Patient has had PET/CT in the past 7 days
5. Patient needs PET/CT in the next 7 days (in the opinion of the clinical team, at the time of eligibility assessment)
6. Clinically unstable for PET/CT (as judged by the treating clinical team, taking into account need for organ support (including inotropes) and capacity to lie flat for the PET/CT)
7. Contraindication to PET/CT (e.g., claustrophobia, persistently elevated blood sugar levels [>12.5mmol/L] that cannot be corrected).
8. Patient no longer willing to participate in the domain - in the days leading up to judging eligibility, it may be helpful to discuss with the patient the potential for PET/CT vs no PET/CT to allow imaging planning
9. Clinician deems participation in this domain is not in the patient's best interests

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Australia Capital TerritoryNSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Concord Repatriation and General Hospital - Concord
Recruitment hospital [5] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [6] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 0 0
St George Hospital - Kogarah
Recruitment hospital [8] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [9] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [10] 0 0
John Hunter Children's Hospital - Newcastle
Recruitment hospital [11] 0 0
Orange Health Service - Orange
Recruitment hospital [12] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [13] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [14] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [15] 0 0
Westmead Hospital - Westmead
Recruitment hospital [16] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [17] 0 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [18] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [19] 0 0
Cairns Hospital - Cairns
Recruitment hospital [20] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [21] 0 0
Ipswich Hospital - Ipswich
Recruitment hospital [22] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [23] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [24] 0 0
Robina Hospital - Robina
Recruitment hospital [25] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [26] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [27] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [28] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [29] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [30] 0 0
Women and Children's Hospital - North Adelaide
Recruitment hospital [31] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [32] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [33] 0 0
Launceston Hospital - Launceston
Recruitment hospital [34] 0 0
Grampians Health - Ballarat
Recruitment hospital [35] 0 0
Bendigo Health - Bendigo
Recruitment hospital [36] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [37] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [38] 0 0
Monash Health - Monash Medical Centre & Jesse McPherson Private Hospital - Clayton
Recruitment hospital [39] 0 0
Western Health - Footscray, Joan Kirner & Sunshine Hospitals - Footscray
Recruitment hospital [40] 0 0
Frankston Hospital - Frankston
Recruitment hospital [41] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [42] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [43] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [44] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [45] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment hospital [46] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [47] 0 0
La Trobe Regional Hospital - Traralgon
Recruitment hospital [48] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [49] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [50] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [51] 0 0
Armadale Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 0 0
2747 - Kingswood
Recruitment postcode(s) [7] 0 0
2217 - Kogarah
Recruitment postcode(s) [8] 0 0
2170 - Liverpool
Recruitment postcode(s) [9] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [10] 0 0
2305 - Newcastle
Recruitment postcode(s) [11] 0 0
2800 - Orange
Recruitment postcode(s) [12] 0 0
2031 - Randwick
Recruitment postcode(s) [13] 0 0
2145 - Westmead
Recruitment postcode(s) [14] 0 0
2500 - Wollongong
Recruitment postcode(s) [15] 0 0
0811 - Tiwi
Recruitment postcode(s) [16] 0 0
4575 - Birtinya
Recruitment postcode(s) [17] 0 0
4870 - Cairns
Recruitment postcode(s) [18] 0 0
4029 - Herston
Recruitment postcode(s) [19] 0 0
4305 - Ipswich
Recruitment postcode(s) [20] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [21] 0 0
4020 - Redcliffe
Recruitment postcode(s) [22] 0 0
4226 - Robina
Recruitment postcode(s) [23] 0 0
4101 - South Brisbane
Recruitment postcode(s) [24] 0 0
4215 - Southport
Recruitment postcode(s) [25] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [26] 0 0
5112 - Adelaide
Recruitment postcode(s) [27] 0 0
5042 - Bedford Park
Recruitment postcode(s) [28] 0 0
5006 - North Adelaide
Recruitment postcode(s) [29] 0 0
7000 - Hobart
Recruitment postcode(s) [30] 0 0
7250 - Launceston
Recruitment postcode(s) [31] 0 0
3350 - Ballarat
Recruitment postcode(s) [32] 0 0
3550 - Bendigo
Recruitment postcode(s) [33] 0 0
3128 - Box Hill
Recruitment postcode(s) [34] 0 0
3168 - Clayton
Recruitment postcode(s) [35] 0 0
3011 - Footscray
Recruitment postcode(s) [36] 0 0
3199 - Frankston
Recruitment postcode(s) [37] 0 0
3220 - Geelong
Recruitment postcode(s) [38] 0 0
3084 - Heidelberg
Recruitment postcode(s) [39] 0 0
3004 - Melbourne
Recruitment postcode(s) [40] 0 0
3050 - Parkville
Recruitment postcode(s) [41] 0 0
3052 - Parkville
Recruitment postcode(s) [42] 0 0
3630 - Shepparton
Recruitment postcode(s) [43] 0 0
3844 - Traralgon
Recruitment postcode(s) [44] 0 0
6150 - Murdoch
Recruitment postcode(s) [45] 0 0
6009 - Nedlands
Recruitment postcode(s) [46] 0 0
6000 - Perth
Recruitment postcode(s) [47] 0 0
6112 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Israel
State/province [7] 0 0
Haifa
Country [8] 0 0
Israel
State/province [8] 0 0
Petah tikva
Country [9] 0 0
Israel
State/province [9] 0 0
Ramat Gan
Country [10] 0 0
Netherlands
State/province [10] 0 0
's-Hertogenbosch
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Nieuwegein
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nijmegen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
Utrecht
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Canterbury
Country [18] 0 0
New Zealand
State/province [18] 0 0
Lower Hutt
Country [19] 0 0
New Zealand
State/province [19] 0 0
Wellington
Country [20] 0 0
New Zealand
State/province [20] 0 0
Hamilton
Country [21] 0 0
New Zealand
State/province [21] 0 0
Tauranga
Country [22] 0 0
New Zealand
State/province [22] 0 0
Whangarei
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
South Africa
State/province [24] 0 0
Johannesburg
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Aberdeen
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Birmingham
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Brighton
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Bristol
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Cambridge
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Cardiff
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Cornwall
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Devon
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Dundee
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Edinburgh
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Glasgow
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Hull
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Leeds
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Liverpool
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Manchester
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Newcastle Upon Tyne
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Nottingham
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxford
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Sheffield
Country [45] 0 0
United Kingdom
State/province [45] 0 0
South Tees
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Southampton
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Stirling
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Stoke
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Berry Consultants
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
McGill University Health Centre/Research Institute of the McGill University Health Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Menzies School of Health Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Aotearoa Clinical Trials
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Queensland University of Technology
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Sunnybrook Health Sciences Centre
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Tan Tock Seng Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Telethon Kids Institute
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
The Peter Doherty Institute for Infection and Immunity
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
The University of Queensland
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
UMC Utrecht
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Radboud University Medical Center
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
King's College London
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Rambam Health Care Campus
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
University College, London
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Houston Medical Research Institute
Address [16] 0 0
Country [16] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Steven Tong
Address 0 0
University of Melbourne / Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lauren Barina
Address 0 0
Country 0 0
Phone 0 0
+61 (03) 8344 1623
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05137119