SNAP: Staphylococcus Aureus Network Adaptive Platform Trial

Sponsor
University of Melbourne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05137119
Collaborator
Menzies School of Health Research (Other), Berry Consultants (Other), Sunnybrook Health Sciences Centre (Other), Tan Tock Seng Hospital (Other), Telethon Kids Institute (Other), The Peter Doherty Institute for Infection and Immunity (Other), The University of Queensland (Other), Queensland University of Technology (Other)
6,000
74
10
45.5
81.1
1.8

Study Details

Study Description

Brief Summary

The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Infection of the bloodstream with the bacterium Staphylococcus aureus (Staphylococcus aureus bacteraemia, SAB) is a serious infection that results in 15-30% of affected patients dying within three months of acquiring the infection. Treatment of this infection requires patients to be hospitalised, treated with prolonged antibiotics through an intravenous line, and carefully examined for the occurrence of complications associated with this condition. At present, there are many treatment options in current use, with no clear agreement as to which of these is best. The SNAP trial aims to identify which treatment options for SAB results in the fewest patients dying within the first 90 days after an infection.

In contrast to a conventional clinical trial, the SNAP trial will examine multiple different treatment options at once. Patients will be randomly assigned to different concurrent treatment options currently considered acceptable in routine medical care, but as the trial progresses, more patients will be assigned to treatments that appear to have better outcomes than those with worse outcomes. The trial will adapt to accumulating trial evidence, on a regular basis, by removing treatment options found to be inferior, incorporating new treatment options, and ensuring that all patients in the trial receive the best treatments once they have been identified. Over time, we hope to determine the best combination of treatment options for patients with SAB.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6000 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Participants enrolled into the study have the option of deciding whether to be randomised in one or more (if available) treatment domains concurrently, if they meet the eligibility criteria.Participants enrolled into the study have the option of deciding whether to be randomised in one or more (if available) treatment domains concurrently, if they meet the eligibility criteria.
Masking:
None (Open Label)
Masking Description:
This is an open-label study
Primary Purpose:
Treatment
Official Title:
Staphylococcus Aureus Network Adaptive Platform Trial
Actual Study Start Date :
Feb 16, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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 (β-lactam) Arm In addition to standard treatment an intravenous β-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 β-lactam). This β-lactam will be intravenous cefazolin 2g every 8 hours. For patients with renal impairment the intravenous cefazolin administration doses will be adjusted.

Drug: Cefazolin
Cefazolin

Drug: Vancomycin
Vancomycin or Daptomycin
Other Names:
  • Daptomycin
  • 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.

    Drug: Cefazolin
    Cefazolin

    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.

    Drug: Penicillin
    benzylpenicillin
    Other Names:
  • Benzylpenicillin
  • Penicillin G
  • 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 for 5 days. No dosage adjustment is needed to renal impairment.

    Drug: Clindamycin
    Clindamycin
    Other Names:
  • Lincomycin
  • 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.

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

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality at 90 days after platform entry [From randomisation (day 1) until day 90]

      The primary endpoint for all cells and domains will be all-cause mortality at 90 days after platform entry. The primary endpoint will be determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries.

    Secondary Outcome Measures

    1. All-cause mortality at 14, 28 and 42 days after platform entry [From randomisation (day 1) until day 14, 28, and 42]

      Determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries.

    2. Duration of survival censored at 90 days after platform entry [From randomisation (day 1) until day 90]

      Determined through a search of hospital databases for a record of a participant's death, or follow-up contact with the participant's community healthcare provider, or follow-up contact with the patient or their nominated carer, or linkage with death registries.

    3. Length of stay of acute index inpatient hospitalisation for those surviving until hospital discharge (excluding HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry. [From randomisation (day 1) until day 90]

      Acute index hospitalisation is defined as a continuous admission to an inpatient healthcare facility where the patient was recruited.

    4. Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry. [From randomisation (day 1) until day 90]

      Total index hospitalisation is defined as a continuous admission to any healthcare facility, including rehabilitation hospitals, and hospital-in-the-home or outpatient parenteral antimicrobial therapy services.

    5. Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry [From randomisation (day 1) until day 90]

      and all deaths within 90 days will be considered '90 days'

    6. 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). [From randomisation (day 1) until day 90]

      A sterile site means any sites deep to the skin and skin structures, including deep visceral and musculoskeletal abscesses that have been obtained in a sterile manner.

    7. Diagnosis of new foci between 14 and 90 days after platform entry. [From randomisation (day 1) until day 90]

      The presence of new foci will be determined by the site investigator and can incorporate clinical, radiological, microbiological and pathological findings.

    8. C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants ≥2 years of age. [From randomisation (day 1) until day 90]

      This means a stool submitted to a clinical laboratory has tested positive for C. difficile toxin or toxin gene.

    9. Number of participants with Serious adverse reactions (SARs) in the 90 days following platform entry [From randomisation (day 1) until day 90]

      SARs defined only as events that are attributable to one or more study interventions

    10. Health economic costs as detailed in the cost utility analysis appendix. [From randomisation (day 1) until day 90]

      Including hospital length of stay, readmissions, and patient employment status.

    11. Proportion of participants who have returned to their usual level of function at day 90. [From randomisation (day 1) until day 90]

      Determined by whether the modified functional bloodstream infection score (FBIS) remained the same or improved between baseline and 90 days after platform entry.

    12. Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version) [From randomisation (day 1) until day 90]

      unable to insert modified ARLG table

    13. Desirability of outcome ranking 2 (SNAP version) [From randomisation (day 1) until day 90]

      unable to insert SNAP DOOR table

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PLATFORM Inclusion Criteria:
    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 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
    1. Where the time of culture collection is not recorded, the time of laboratory registration of the sample will be used as an alternative
    1. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician

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

    3. Known previous participation in SNAP

    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

    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) or severe diarrhoea from any cause

    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

    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.
    1. 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.

    MRSA TREATMENT DOMAIN (backbone)

    Inclusion Criteria:
    1. MRSA confirmed microbiologically
    Exclusion Criteria:
    1. Time to allocation reveal is >72 hours from time of index blood culture collection

    2. Severe allergy to any beta-lactam (including cefazolin)

    3. Immediate severe allergy: Anaphylaxis/angioedema

    4. 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.

    5. Non-severe rash to cefazolin

    1. 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.
    1. Severe allergy or non-severe rash to both vancomycin AND daptomycin
    1. 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.
    1. Treating team deems enrolment in the domain is not in the best interest of the patient

    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

    Exclusion Criteria:

    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

    1. 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
    1. 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. Known presence of intravascular clot (excluding superficial peripheral IV line-related thrombophlebitis), graft or other intravascular prosthetic material

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Canberra Hospital Garran Australia Capital Territory Australia 2605
    2 Blacktown Hospital Blacktown New South Wales Australia 2148
    3 Royal Prince Alfred Hospital Camperdown New South Wales Australia 2050
    4 Concord Repatriation and General Hospital Concord New South Wales Australia 2139
    5 St Vincent's Hospital Sydney Darlinghurst New South Wales Australia 2010
    6 Nepean Hospital Kingswood New South Wales Australia 2747
    7 St George Hospital Kogarah New South Wales Australia 2217
    8 Liverpool Hospital Liverpool New South Wales Australia 2170
    9 John Hunter Hospital New Lambton Heights New South Wales Australia 2305
    10 Prince of Wales Hospital Randwick New South Wales Australia 2031
    11 Sydney Children's Hospital Randwick New South Wales Australia 2031
    12 The Children's Hospital at Westmead Westmead New South Wales Australia 2145
    13 Westmead Hospital Westmead New South Wales Australia 2145
    14 Wollongong Hospital Wollongong New South Wales Australia 2500
    15 Royal Darwin Hospital Tiwi Northern Territory Australia 0811
    16 Sunshine Coast University Hospital Birtinya Queensland Australia 4575
    17 Cairns Hospital Cairns Queensland Australia 4870
    18 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    19 Logan Hospital Meadowbrook Queensland Australia 4131
    20 Queensland Children's Hospital South Brisbane Queensland Australia 4101
    21 Gold Coast University Hospital Southport Queensland Australia 4215
    22 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    23 Flinders Medical Centre Bedford Park South Australia Australia 5042
    24 Women's and Children's Hospital North Adelaide South Australia Australia 5006
    25 Royal Hobart Hospital Hobart Tasmaina Australia 7000
    26 Launceston Hospital Launceston Tasmania Australia 7250
    27 Ballarat Base Hospital Ballarat Victoria Australia 3350
    28 Bendigo Health Bendigo Victoria Australia 3550
    29 Box Hill Hospital Box Hill Victoria Australia 3128
    30 Monash Medical Centre Clayton Victoria Australia 3168
    31 Western Health Footscray Victoria Australia 3011
    32 Frankston Hospital Frankston Victoria Australia 3199
    33 Geelong Hospital Geelong Victoria Australia 3220
    34 Austin Hospital Heidelberg Victoria Australia 3084
    35 Alfred Hospital Melbourne Victoria Australia 3004
    36 Royal Melbourne Hospital Parkville Victoria Australia 3050
    37 Royal Children's Hospital Melbourne Parkville Victoria Australia 3052
    38 Goulburn Valley Health Shepparton Victoria Australia 3630
    39 La Trobe Regional Hospital Traralgon Victoria Australia 3844
    40 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    41 Perth Children's Hospital Nedlands Western Australia Australia 6009
    42 Royal Perth Hospital Perth Western Australia Australia 6000
    43 University of Calgary - Foothills Medical Center Calgary Alberta Canada T2N4Z6
    44 University of Alberta Hospital Edmonton Alberta Canada T6G2B7
    45 Richmond General Hospital Richmond British Columbia Canada V6X1A2
    46 Vancouver General Hospital Vancouver British Columbia Canada V5Z1M9
    47 Health Sciences Centre Winnipeg Winnipeg Manitoba Canada R3A1R9
    48 Eastern Health - Health Sciences Centre (Memorial University) Saint John's Newfoundland and Labrador Canada A1B3V6
    49 University Health Network East York Ontario Canada M5G2C4
    50 Hamilton Health Sciences Center Hamilton Ontario Canada L8P1A2
    51 Kingston Health Sciences Centre Kingston Ontario Canada K7L2V7
    52 Ottawa Hospital Ottawa Ontario Canada K1H8L6
    53 Unity Health Toronto Ontario Canada M1L 1W1
    54 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5
    55 Sinai Heath System Toronto Ontario Canada M5G1X5
    56 Jewish General Hospital Montréal Quebec Canada H3T1E2
    57 McGill University Health Centre Montréal Quebec Canada H4A3J1
    58 University of Sherbrooke Health Centre- USHC/CHUS Sherbrooke Quebec Canada J1H 5H3
    59 Rambam Health Care Campus Haifa Israel 310960
    60 Beilinson Hospital Petah tikva Israel 49100
    61 Auckland City Hospital Grafton Auckland New Zealand 1023
    62 Middlemore Hospital Otahuhu Auckland New Zealand 1640
    63 North Shore Hospital Takapuna Auckland New Zealand 0620
    64 Christchurch Hospital Christchurch Canterbury New Zealand 8011
    65 Hutt Valley Hospital Boulcott Lower Hutt New Zealand 5010
    66 Nelson Hospital Nelson South Nelson New Zealand 7010
    67 Dunedin Hospital Dunedin Otago New Zealand 9016
    68 Wellington Hospital Newtown Wellington New Zealand 6021
    69 Waikato Hospital Hamilton New Zealand 3240
    70 Tauranga Hospital Tauranga New Zealand 3112
    71 Whangarei Hospital Whangarei New Zealand 0148
    72 National University Hospital Singapore Singapore 119228
    73 Singapore General Hospital Singapore Singapore 168753
    74 Tan Tock Seng Hospital Singapore Singapore 308433

    Sponsors and Collaborators

    • University of Melbourne
    • Menzies School of Health Research
    • Berry Consultants
    • Sunnybrook Health Sciences Centre
    • Tan Tock Seng Hospital
    • Telethon Kids Institute
    • The Peter Doherty Institute for Infection and Immunity
    • The University of Queensland
    • Queensland University of Technology

    Investigators

    • Study Chair: A/Prof Steven Tong, University of Melbourne
    • Study Chair: Prof Joshua Davies, Menzies School of Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Melbourne
    ClinicalTrials.gov Identifier:
    NCT05137119
    Other Study ID Numbers:
    • CT19029
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    No Results Posted as of Mar 10, 2022