Clinical trial NCT05137119: Staphylococcus Aureus Network Adaptive Platform Trial
Official title: Staphylococcus Aureus Network Adaptive Platform Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Staphylococcus Aureus Bacteremia
Keywords: Methicillin-resistant Staphylococcus aureus (MRSA)
Methicillin-susceptible Staphylococcus aureus (MSSA)
Penicillin-susceptible Staphylococcus aureus (PSSA)
Staphylococcus aureus
S. aureus
Staph Aureus Bacteremia (SAB)
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Berry Consultants
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Menzies School of Health Research
name: Aotearoa Clinical Trials
name: Queensland University of Technology
name: Sunnybrook Health Sciences Centre
name: Tan Tock Seng Hospital
name: Telethon Kids Institute
name: The Peter Doherty Institute for Infection and Immunity
name: The University of Queensland
name: UMC Utrecht
name: Radboud University Medical Center
name: King's College London
name: Rambam Health Care Campus
name: University College, London
name: Houston Medical Research Institute
First posted: 2021-11-30
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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).

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.

The SNAP Trial infrastructure will also support a number of sub-studies. A list of all active sub-studies can be found on the SNAP website: https://www.snaptrial.com.au/substudies.

Eligibility criteria: 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. 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

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) 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

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 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.

Exclusion Criteria:

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

Primary outcomes:
measure: All-cause mortality at 90 days after platform entry
timeFrame: From randomisation (day 1) until day 90
Secondary outcomes:
measure: All-cause mortality at 14, 28 and 42 days after platform entry
timeFrame: From randomisation (day 1) until day 14, 28, and 42
measure: Duration of survival censored at 90 days after platform entry
timeFrame: From randomisation (day 1) until day 90
measure: Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab).
timeFrame: From randomisation (day 1) until discharge from acute inpatient facilities, truncated at 90 days.
measure: Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab)
timeFrame: From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days
measure: Time to being discharged alive from the total index hospitalisation (including HITH/COPAT/OPAT/rehab) truncated at 90 days after platform entry
timeFrame: From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days
measure: 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).
timeFrame: From randomisation (day 1) until day 90
measure: Diagnosis of new foci between 14 and 90 days after platform entry.
timeFrame: From randomisation (day 1) until day 90
measure: C. difficile diarrhoea as determined by a clinical laboratory in the 90 days following platform entry for participants ≥2 years of age.
timeFrame: From randomisation (day 1) until day 90
measure: Number of participants with Serious adverse reactions (SARs) in the 90 days following platform entry
timeFrame: From randomisation (day 1) until day 90
measure: Health economic costs as detailed in the cost utility analysis appendix.
timeFrame: From randomisation (day 1) until day 90
measure: Proportion of participants who have returned to their usual level of function at day 90.
timeFrame: From randomisation (day 1) until day 90
measure: Desirability of outcome ranking 1 (modified Antibiotic Resistance Leadership Group version)
timeFrame: From randomisation (day 1) until day 90
measure: Desirability of outcome ranking 2 (SNAP version)
timeFrame: From randomisation (day 1) until day 90
measure: Number of antibiotic days (IV and/or oral/enteral)
timeFrame: From randomisation (day 1) until day 90
measure: Days alive and free of antibiotics
timeFrame: From randomisation (day 1) until day 90
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Canberra Hospital
state: Australia Capital Territory
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation and General Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Children's Hospital
state: New South Wales
city: Orange
country: Australia
facility: Orange Health Service
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Tiwi
country: Australia
facility: Royal Darwin Hospital
state: Northern Territory
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich Hospital
state: Queensland
city: Meadowbrook
country: Australia
facility: Logan Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Robina
country: Australia
facility: Robina Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: North Adelaide
country: Australia
facility: Women and Children's Hospital
state: South Australia
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Launceston
country: Australia
facility: Launceston Hospital
state: Tasmania
city: Ballarat
country: Australia
facility: Grampians Health
state: Victoria
city: Bendigo
country: Australia
facility: Bendigo Health
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Children's Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre & Jesse McPherson Private Hospital
state: Victoria
city: Footscray
country: Australia
facility: Western Health - Footscray, Joan Kirner & Sunshine Hospitals
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health - University Hospital Geelong
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Children's Hospital Melbourne
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Traralgon
country: Australia
facility: La Trobe Regional Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Perth
country: Australia
facility: Armadale Hospital
state: Western Australia
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Calgary
country: Canada
facility: Rockyview Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Richmond
country: Canada
facility: Richmond Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Fraser Health Authority - Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
city: Winnipeg
country: Canada
facility: Grace Hospital
state: Manitoba
city: Saint John's
country: Canada
facility: Eastern Health - Health Sciences Centre (Memorial University)
state: Newfoundland and Labrador
city: Saint John's
country: Canada
facility: Eastern Regional Health Authority - St. Clare's Mercy Hospital
state: Newfoundland and Labrador
city: East York
country: Canada
facility: Toronto East Health Network - Michael Garron Hospital
state: Ontario
city: East York
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre - Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital, LHSC
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Health - Niagara Falls Site
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Sault-Sainte-Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health - St. Catharines Site
state: Ontario
city: Toronto
country: Canada
facility: Unity Health - St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sinai Heath System - Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto - St Joseph's Health Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
city: Laval
country: Canada
facility: CISSS - Hôpital Cité-de-la-Santé Hospital
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre - Montral General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre - Montreal Children's Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre - Royal Victoria Hospital
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Hôpital Régional de Saint Jérôme
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke Health Centre - Hospital Fleurimont
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke Health Centre - Hotel Dieu
state: Quebec
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah tikva
country: Israel
facility: Beilinson Hospital
city: Petah tikva
country: Israel
facility: Schneider Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Centre
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Nieuwegein
country: Netherlands
facility: Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Takapuna
country: New Zealand
facility: North Shore Hospital
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Boulcott
country: New Zealand
facility: Hutt Valley Hospital
state: Lower Hutt
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Auckland
country: New Zealand
facility: Starship Hospital
city: Auckland
country: New Zealand
facility: KidzFirst
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Whangarei
country: New Zealand
facility: Whangarei Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals
city: Bristol
country: United Kingdom
facility: North Bristol
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospitals
city: Devon
country: United Kingdom
facility: Royal Devon University Healthcare
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Edinburgh
country: United Kingdom
facility: Lothian Western General
city: Glasgow
country: United Kingdom
facility: Greater Glasgow and Clyde
city: Glasgow
country: United Kingdom
facility: NHS Golden Jubilee
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospital
city: London
country: United Kingdom
facility: Barts Health
city: London
country: United Kingdom
facility: Great Ormond Street
city: London
country: United Kingdom
facility: Guys and St Thomas'
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Royal Free London
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Whittington Health
city: Manchester
country: United Kingdom
facility: Manchester University Hospitals
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
city: South Tees
country: United Kingdom
facility: South Tees Hospitals
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Stirling
country: United Kingdom
facility: NHS Forth Valley
city: Stoke
country: United Kingdom
facility: University Hospitals of North Midlands
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: University of Melbourne / Melbourne Health
name: Prof Steven Tong
role: STUDY_CHAIR
affiliation: Menzies School of Research / Hunter New England Medical Centre
name: Prof Joshua Davies
role: STUDY_CHAIR
References:
citation: Tong SYC, Mora J, Bowen AC, Cheng MP, Daneman N, Goodman AL, Heriot GS, Lee TC, Lewis RJ, Lye DC, Mahar RK, Marsh J, McGlothlin A, McQuilten Z, Morpeth SC, Paterson DL, Price DJ, Roberts JA, Robinson JO, van Hal SJ, Walls G, Webb SA, Whiteway L, Yahav D, Davis JS; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022 Nov 30;75(11):2027-2034. doi: 10.1093/cid/ciac476.
citation: Symons TJ, Straiton N, Gagnon R, Littleford R, Campbell AJ, Bowen AC, Stewart AG, Tong SYC, Davis JS. Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial. Trials. 2022 Dec 28;23(1):1055. doi: 10.1186/s13063-022-07023-z.
citation: Malhame I, Hardy E, Cheng MP, Tong SY, Bowen AC. Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial. Obstet Med. 2023 Mar;16(1):3-4. doi: 10.1177/1753495X231163351. Epub 2023 Mar 22. No abstract available.
citation: Henderson A, Cheng MP, Chew KL, Coombs GW, Davis JS, Grant JM, Gregson D, Giulieri SG, Howden BP, Lee TC, Nguyen V, Mora JM, Morpeth SC, Robinson JO, Tong SYC, Van Hal SJ; Microbiology Working Group of the Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Group. A multi-site, international laboratory study to assess the performance of penicillin susceptibility testing of Staphylococcus aureus. J Antimicrob Chemother. 2023 Jun 1;78(6):1499-1504. doi: 10.1093/jac/dkad116.
citation: de Kretser D, Mora J, Bloomfield M, Campbell A, Cheng MP, Guy S, Hensgens M, Kalimuddin S, Lee TC, Legg A, Mahar RK, Marks M, Marsh J, McGlothin A, Morpeth SC, Sud A, Ten Oever J, Yahav D, Bonten M, Bowen AC, Daneman N, van Hal SJ, Heriot GS, Lewis RJ, Lye DC, McQuilten Z, Paterson DL, Owen Robinson J, Roberts JA, Scarborough M, Webb SA, Whiteway L, Tong SYC, Davis JS, Walls G, Goodman AL; SNAP Early Oral Switch Domain-Specific Working Group and SNAP Global Trial Steering Committee; SNAP Trial Group. Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol. Clin Infect Dis. 2024 Oct 15;79(4):871-887. doi: 10.1093/cid/ciad666.
citation: Mahar RK, McGlothlin A, Dymock M, Lee TC, Lewis RJ, Lumley T, Mora J, Price DJ, Saville BR, Snelling T, Turner R, Webb SA, Davis JS, Tong SYC, Marsh JA; SNAP Global Trial Steering Committee. A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial. Trials. 2023 Dec 6;24(1):795. doi: 10.1186/s13063-023-07718-x.