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Staphylococcus Aureus Network Adaptive Platform Trial

ConditionStaphylococcus Aureus Bacteremia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Melbourne

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Staphylococcus aureus complex grown from ≥1 blood culture

Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the time of blood culture collection until the time of eligibility assessment)

Disqualifiers

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)

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.

Known previous participation in the randomised SNAP platform

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Cefazolin

    Drug

    Cefazolin

  • Penicillin

    Drug

    benzylpenicillin

  • Clindamycin

    Drug

    Clindamycin

  • Vancomycin

    Drug

    Vancomycin or Daptomycin

  • Effectiveness of early switch to oral antibiotics

    Other intervention

    This involves testing a strategy rather than individual antibiotic agents

  • Whole body FDG PET/CT Imaging

    Radiation

    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.

Treatment groups

8,000 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Methicillin-resistant staphylococcus aureus (MRSA) - Standard Therapy Arm (backbone therapy)No intervention 0 interventions
Group B: Methicillin-resistant staphylococcus aureus (MRSA) - Standard + B-Lactam Arm (backbone therapy)Experimental treatment 2 interventions
Group C: Methicillin-susceptible staphylococcus aureus (MSSA) - Standard Therapy Arm (backbone therapy)No intervention 0 interventions
Group D: Methicillin-susceptible staphylococcus aureus (MSSA) - Interventional Arm (backbone therapy)Experimental treatment 1 intervention
Group E: Penicillin-susceptible staphylococcus aureus (PSSA) - Standard Therapy Arm (backbone therapy)No intervention 0 interventions
Group F: Penicillin-susceptible staphylococcus aureus (PSSA) - Interventional Arm (backbone therapy)Experimental treatment 1 intervention
Group G: No adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy armNo intervention 0 interventions
Group H: Adjunctive treatment in combination with MRSA or MSSA or PSSA backbone therapy armExperimental treatment 1 intervention
Group I: Continue intravenous antibiotic therapies (backbone +/- adjunctive therapy) - standard of care armNo intervention 0 interventions
Group J: Switch to oral antibiotics at trial day 7 (+/- 2 days) or Day 14 (+/- 2 days) if eligible.Experimental treatment 1 intervention
Group K: No PET/CT scan - standard of care armNo intervention 0 interventions
Group L: PET/CT scan at trial day 7 (+/- 2 days) if eligibleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality at 90 days after platform entry

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.

Time frame
From randomisation (day 1) until day 90

Secondary outcomes

1

Core1: All-cause mortality at 14, 28 and 42 days after platform entry

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.

Time frame
From randomisation (day 1) until day 14, 28, and 42
2

Core2: Duration of survival censored at 90 days after platform entry

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.

Time frame
From randomisation (day 1) until day 90
3

Core3: Length of stay of acute index inpatient hospitalisation for those surviving until discharge from acute inpatient facilities (excluding HITH/COPAT/OPAT/rehab).

Acute index hospitalisation is defined as continuous hospital admission to one or more acute inpatient facilities for the index episode. This does not include HITH/OPAT/COPAT and stepdown inpatient rehabilitation/post-acute care. It does include admission to acute care hospitals immediately preceding and following those at the enrolling site.

Time frame
From randomisation (day 1) until discharge from acute inpatient facilities, truncated at 90 days.
4

Core4: Length of stay of total index hospitalisation for those surviving until hospital discharge (including HITH/COPAT/OPAT/rehab)

Total index hospitalisation is defined as continuous hospital admission to one or more inpatient facilities for the index episode, including HITH/OPAT/COPAT and stepdown inpatient rehabilitation/post-acute care (if continuous with the initial inpatient admission). It includes admission to acute care hospitals immediately preceding and following those at the enrolling site.

Time frame
From randomisation (day 1) to discharge from total index hospitalisation, truncated at 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Melbourne

Lead sponsor

Berry Consultants

Collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Menzies School of Health Research

Collaborator

Aotearoa Clinical Trials

Collaborator

Queensland University of Technology

Collaborator

Sunnybrook Health Sciences Centre

Collaborator

Tan Tock Seng Hospital

Collaborator

Telethon Kids Institute

Collaborator

The Peter Doherty Institute for Infection and Immunity

Collaborator

The University of Queensland

Collaborator

UMC Utrecht

Collaborator

Radboud University Medical Center

Collaborator

King's College London

Collaborator

Rambam Health Care Campus

Collaborator

University College, London

Collaborator

The Methodist Hospital Research Institute

Collaborator

Source ClinicalTrials.gov
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