Further Information

Regional Sponsors

Berry Consultancy based in the United States is providing statistical consultancy on the Bayesian adaptive study design.

The Australian Society for Infectious Diseases Clinical Research Network (ASID CRN) is a collaborator of the SNAP trial. ASID CRN is a network of infectious diseases professionals who collaborate to advance and promote quality clinical infectious diseases research in Australia.

‍Spiral software is a New Zealand company that specialises in study management software and has built the SNAP trial database and registry database. Spiral have extensive experience in development and building of eCRF/database software solutions for large international multi-factorial, adaptive platform clinical trials such as REMAP-CAP and ASCOT.

SNAP will be working closely with the Australian Group for Antimicrobial Resistance (AGAR) Australian Staphylococcal sepsis outcomes program (ASSOP). ASSOP has been a long standing program to monitor clinical and microbiological trends in S. aureus bloodstream infections. More than 30 major hospital laboratories around Australia contribute S. aureus isolates for centralised testing and whole genome sequencing (for MRSA). Yearly reports are provided by ASSOP. The ASSOP data and program have been an essential underpinning to SNAP in Australia. In this collaboration, ASSOP will share S. aureus isolates of patients enrolled in SNAP and provide intellectual input to microbiological sub-studies through membership on the SNAP Microbiology Working Group.

New information about the treatments being studied may become available during the course of the study. You will be kept informed of any significant new findings that may affect your willingness to continue in the study. If you wish to withdraw from the study once it has started, you can do so at any time without having to give a reason.

If you suffer any injuries or complications as a result of this study, you should contact the study doctor as soon as possible, who will assist you in arranging appropriate medical treatment. 
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In addition, you may have a right to take legal action to obtain compensation for any injuries or complications resulting from the study.  Compensation may be available if your injury or complication is sufficiently serious and is caused by unsafe drugs or equipment, or by the negligence of one of the parties involved in the study. You do not give up any legal rights to compensation by participating in this study.

A domain within this trial may be stopped unexpectedly if an unacceptable side effect is found. For those participants that experienced the side effect, continual care will be provided to ensure their well-being.
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Active follow-up in the study is for 90 days (approximately 3 months). The study design allows for the study to continue to adapt and add new interventions. SNAP has the potential to continue to recruit to different interventions indefinitely. However, if the study was to end, all active participants would be followed up until they have reached day 90 on the study. Data will be reviewed and analysed for outcomes after the last trial participant enrolled reaches day 90. Results will be published and treatment guidelines will be updated according to the results.

The SNAP registry is a dataset containing a small subset of information that will be used to inform the quality of care of S. aureus bloodstream infection patients and to monitor changes in practice that occur during the lifetime of the SNAP trial. All participants that have agreed to take part in the SNAP trial will also take part in the SNAP registry. Those who do not want to take part in the main SNAP trial will have the opportunity to contribute their data to the SNAP registry if they choose.

Information collected in the SNAP registry will also be used for data linkage. Data linkage is the process of connecting data about the same person from multiple sources of information. These sources of information are usually large datasets maintained by government agencies, such as birth, marriage, health-related and death records. The SNAP registry data will be linked with hospital, emergency department and death records datasets. For specific sub-studies, we may ask for additional permission to link to other datasets (any such use of data will also need to be approved by ethics committees and those who hold such data).
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In order to link your non-identifiable data collected in the SNAP registry to your non-identifiable data to other datasets, some of your identifiable information (such as your name and address) will need to be collected and stored. This identifiable information will be collected by the study team at your hospital and entered into a purpose-built secure database that only your local hospital study team, data coordinator from the trial sponsor and linkage provider will have access to. The data coordinator will send your identifiable information securely to the organisations who conduct the confidential data linkage. Any information used from these data sources will be treated completely confidentially and used for the purposes of the research only. 

The diagram below outlines how identifiable and non-identifiable information, and data linkage are handled in the registry. For more information on data linkage, please follow this link.