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Staphylococcus aureus (S. aureus) bloodstream infection is one of the most serious bacterial infections worldwide. All patients need to be hospitalised and adults typically will receive a minimum of two weeks intravenous antibiotics.
S. aureus normally lives on your skin or in your nose. It is commonly called ‘golden staph’ as it looks golden ('aureus') when it is grown on an agar plate, and it looks like clusters of grapes ('staphylococcus') under a microscope. When S. aureus gets into your blood through a sore or a cut in the skin, this can cause a bloodstream infection.
S. aureus bloodstream infections can make you very sick and can affect parts of your body like the lungs, heart, bones, and muscles.
There are three types of S. aureus blood stream infection:
• Penicillin-susceptible S. aureus which is also called PSSA
• Methicillin-susceptible S. aureus which is also called MSSA
• Methicillin-resistant S. aureus which is also called MRSA
While we have effective antibiotic treatments for S. aureus bloodstream infections, it is not known which of these are the best. There are only a few published studies that compare current available treatments. Fewer than 3,000 participants combined have ever been enrolled in published randomised controlled trials for treatments of S. aureus bloodstream infection. The SNAP study will evaluate a range of antibiotic treatments for S. aureus with the aim of improving outcomes for patients.
There are currently three parts to the study, which we call ‘domains’. To find out more about each of these, please watch the videos below:
• Antibiotic backbone domain
• Adjunctive treatment domain
• Early oral switch domain
• PET/CT domain
The SNAP study is being conducted by researchers across Australia, Canada, New Zealand, Singapore, Israel and the United Kingdom, and has the potential to include sites elsewhere in the world.
The lead sponsor for the study is The Peter Doherty Institute for Infection and Immunity (The Doherty Institute), University of Melbourne.
Each country conducting the study will have their own regional sponsor.
If you decide to participate in the study, you will be asked to give consent. This means you will be asked to sign a consent form, which you will also be given a copy to keep. You will then be randomly allocated to different treatments in up to three ‘domains’. To learn more about each domain, see our videos here. Each domain has certain eligibility criteria to ensure it is safe for you to participate.
If you agree to take part in SNAP you can withdraw at any time without giving a reason; this will not affect any of the care you receive.
Additional information for Paediatrics & Youth (SNAP-PY) Participants:
In addition to the procedures for obtaining informed consent outlined above, additional age-appropriate information sheets will be provided to children and adolescents and their families, providing further information about SNAP-PY.
Parents and caregivers will be approached to provide informed consent.
Children > 12 years will have their assent to participate in the trial documented.
It is ok if you do not want to take part, this decision will not affect any of the care or treatments you will receive while you are in hospital.
If you decide not to participate in the study, you will be given the standard antibiotic treatments that are used in this hospital- which may actually be the same treatments you would have received in the study.
S. aureus bloodstream infections are always treated with antibiotics. The antibiotics used in this study are not experimental drugs. In fact, the antibiotics are already very widely and frequently used in clinical care.
Most side effects from the antibiotics used are mild, such as diarrhoea, thrush and a rash. Very rarely, more severe side effects might happen, such as liver or kidney impairment, muscle damage or low white cells, but these usually get better when the treatment is stopped. As part of this study the treating doctors will closely monitor you for all of these side effects during your hospital admission and the study medication will be stopped if you experience any severe side effects.
Below is a list of antibiotics which may be used in this study, depending on your age, what country you live in and what domains you take part in:
Treatments that you may be randomly allocated to receive:
Treatments that you may be prescribed by your treating doctor:
Please note: The antibiotics listed in the table above are representative for each drug. If you want to know more about the specific brand that you have been prescribed, please use the following links and search using the antibiotic name:
Australia: Australian Register of Therapeutic Goods
Canada: Canadian Drug and Health Product Register
Israel: TBC
New Zealand: MEDSAFE Consumer Medicine Information
Singapore: TBC
United Kingdom: MHRA Register of Products
A Positron Emission Tomography/Computed Tomography Scan (PET/CT scan) is a type of x-ray that involves the use of a special dye and special camera to take a detailed picture of your body. This picture of your body can accurately identify areas of active infection.
When you have the scan, you will need to lie on a scanning bed, and it will move your body through the tube-shaped camera scanner. The scan usually takes between 30-60 minutes.
Although the scan is painless, it can be a bit loud and uncomfortable, as you must lie still in a small space.
To learn more about PET/CT scans, click here.
How does the dye work?
This special dye uses a small amount of radioactive materials (called radiotracers) that is put in a glucose (sugar) syrup. Areas of the body with an active infection will have increased ‘uptake’ of the glucose and ‘light up’ on the scan.
When the dye is given by IV, you may feel some discomfort or a slight stinging feeling and you may get have a slight metallic taste in your mouth.
How much radiation will I be exposed to as part of the PET/CT domain?
Radiation is measured in a unit called millisieverts (mSv). We are all exposed to about 2mSv radiation every year due to background radiation. Background radiation is a part of everyday lives – radioactive particles are found in the air we breathe, the food we eat, the water we drink and also exist naturally in our bodies.
Having an x-ray or a PET/CT scan means you are exposed to more of these particles than normal. On average, a PET/CT scan gives a dose of approximately 5.6 mSvs., which is equivalent to about 5 years of background radiation.
PET/CT scans are very safe. There are no side effects associated with the radioactive tracers, which only remain in your body for a short time. In addition, the dose of radiation is very small — similar to several years’ worth of natural radiation from the environment.
There are no costs associated with participating in this study, nor will you be paid. All medication required as part of the study will be provided to you free of charge.
If you have any complaints about the conduct of the study or any of the study team you have the right to make a complaint, this will not affect any care or treatment that you are receiving. For contact details to make a complaint please click on the relevant country:
Reviewing Human Research Ethics Committee:
Melbourne Health Complaints contact person
Name: Director Research Governance and Ethics
Position: Complaints Manager
Telephone: (03) 9342 8530
Email: Research@mh.org.au
Western Australia Human Research Ethics Committee:
If you are considering being a part of this research project, or agree to participate, you can ask questions or raise issues with the researchers at any time. If you are not satisfied with the response of researchers, you can raise ethics issues or concerns and make any complaints about this research project by contacting the Western Australian Aboriginal Health Ethics Committee (WAAHEC) on (08) 9227 1631 or by emailing to ethics@ahcwa.org. All research participants are entitled to retain a copy of any Participant Information Form and/or Participant Consent Form relating to this research project..
Sponsor:
University of Melbourne Name: Office of Research Ethics and Integrity
Email: research-integrity@unimelb.edu.au
Website: https://research.unimelb.edu.au/work-with-us/ethics-and-integrity
SNAP Trial Management Group:
Telephone: 03 8344 2554
Email: snap-trial@unimelb.edu.au
Hospital Research Governance Office:
Western Australia
Fiona Stanley Hospital
For matters relating to research at the site at which the participant is participating, the details of the local site complaints person are:
Position: Manager Research Support and Development
Ph: 08 6152 3214
Email: SMHS.RGO@health.wa.gov.au
Perth Children's Hospital
Any complaints regarding the conduct of the project can be directed to the Executive Director Medical Services, Child and Adolescent Health Services via hospital switchboard on 08 6456 2222 with reference number RGS000004691.
South Australia
Northern Territory
Queensland
Gold Coast University Hospital
If are participating through Gold Coast Hospital and you have any complaints about any aspect of the project, the way it is being conducted, or any questions about being a research participant in general, please contact:
Name: Vanessa Druett
Position: Research Governance Lead
Telephone: 07 5687 3880
Email: GCHResearch@health.qld.gov.au
Queensland Children's Hospital
The Royal Melbourne Hospital Human Research Ethics Committee (HREC) has approved this study. If you have any concerns and/or complaints about the project, the way it is being conducted or your child’s rights as a research participant, and would like to speak to someone independent of the project, please contact:
Local Governance Contact: Research Governance Officer
Phone: 07 3069 7008
EMail: CHQ_RGO@health.qld.gov.au
Cairns Hospital
The Royal Melbourne Hospital Human Research Ethics Committee (HREC) has approved this study. If you have any concerns and/or complaints about the project, the way it is being conducted or your child's rights as a research participant, and would like to speak to someone independent of the project, please contact:
Local Governance Contact: Marisa Ross, A/Research Governance Officer, Cairns Hospital
Email: RGO_Cairns@health.qld.gov.au
New South Wales
Hunter New England Local Health District (John Hunter & John Hunter Children's Hospitals):
Should you have concerns or a complaint about the manner in which the research is conducted, it may be given to the researcher, or, if an independent person is preferred, please contact the HNE Research Office, Hunter New England Local Health District, Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305. Telephone: 02 4921 4140. Email: HNELHDResearchOffice@health.nsw.gov.au and quote the reference number "STE03594".
South Western Sydney Local Health District (Liverpool Hospital):
The conduct of this study at Liverpool Hospital has been authorised by the South Western Sydney Local Health District, any person with concerns or complaints about the conduct of this study may also contact the Research Governance Officer on (02) 8738 8304, email: SWSLHD-Ethics@health.nsw.gov.au and quote project number “2021/STE03597”
South Eastern Sydney Local Health District (St George Hospital):
The conduct of this study at St George Hospital has been authorised by the South Eastern Sydney Local Health District. Should you have any complaints or concerns about the manner in which the research is conducted, please use the contact details below.
Name: Research Support Office
Telephone: 02 9382 3152
Email: SESLHD-RSO@health.nsw.gov.au
Illawarra Shoalhaven Local Health District (Wollongong Hospital):
Should you have any complains or concerns about the manner in which the research is conducted, please contact the ISLHD Research Governance using the contact details below.
Name: ISLHD Research Governance Officer
Position: Research Governance Officer
Telephone: (02) 4253 4800
Email: ISLHD-ResearchGovernance@health.nsw.gov.au
Western Sydney Local Health District (Blacktown Hospital):
Should you have any complains or concerns about the manner in which the research is conducted, please contact the WSLHD General Manager using the contact details below.
Complaints Contact: Office of the General Manager, Blacktown-Mt Druitt Hospitals
Telephone: (02) 9881 8000 - (Blacktown Hospital switchboard) and ask to be connected to the Office of the General Manager
Email: wslhd-bmdhexec@health.nsw.gov.au
Western Sydney Local Health District (Westmead Hospital):
Should you have any complains or concerns about the manner in which the research is conducted, please contact the WSLHD General Manager using the contact details below.
Complaints Contact: Patient Experience Unit
Telephone: (02) 8890 7014
Email: Wslhd-westmead-feedback@health.nsw.gov.au
Sydney Local Health District (Concord Repatriation General Hospital):
The conduct of this study at Concord Hospital has been authorised by the Sydney Local Health District. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer on 02 9767 5622 or SLHD-ConcordEthics@health.nsw.gov.au and quote protocol number 2020/STE03596
Sydney Local Health District (Royal Prince Alfred Hospital):
The conduct of this study at the Royal Prince Alfred Hospital has been authorised by the Sydney Local Health District. Any person with concerns or complaints about the conduct of this study may also contact the Research Governance Officer on 02 95157899 and quote the REGIS STE number 2021/STE03600.
Sydney Children’s Hospital Network (Children’s Hospital at Westmead):
The conduct of this study at the Children’s Hospital at Westmead has been authorised by the Sydney Children’s Hospital Network Research Governance Office. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer via SCHN-Governance@health.nsw.gov.au and quote protocol number 2021/STE03606.
Sydney Children’s Hospital Network (Sydney Children’s Hospital Randwick):
The conduct of this study at the Sydney Children’s Hospital Randwick has been authorised by the Sydney Children’s Hospital Network Research Governance Office. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer via SCHN-Governance@health.nsw.gov.au and quote protocol number 2021/STE03605.
Nepean Blue Mountains Local Health District (Nepean Hospital):The conduct of this study has been authorised by the Nepean Blue Mountains Local Health District. Any person with concerns or complaints about the conduct of this study may contact:
Position: The Research Governance Officer
Phone: (02) 4734 1998
Email: NBMLHD-RGO@health.nsw.gov.au
OR
Position: The Nepean Hospital Feedback & Complaints Team
Phone: (02) 4734 3174
Email: NBMLHD-NepeanFeedback@health.nsw.gov.au
Australian Capital Territory
Victoria
Monash Health (Monash Medical Centre and Monash Children's Hospital):
For matters relating to research at the site at which you are participating, and if you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then the details of the local site complaints person are:
Name: Deborah Dell
Position: Director, Research Operations
Telephone: 03 9594 4611
Email: research@monashhealth.org
Barwon Health (University Hospital Geelong):
Name: Consumer Liaison Officer
Department: Safety, Quality and Improvement Unit
Telephone: (03) 4215 1251
Email: consumer.liaisonofficer@barwonhealth.org.au
Peninsula Health (Frankston Hospital):
For matters relating to research at the site at which you are participating, and if you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then the details of the local site complaints person are:
Position: The Manager Office for Research
Telephone: 03 9784 2679
Email: researchethics@phcn.vic.gov.au
Eastern Health (Box Hill Hospital):
For general queries, feedback or complaints relating to research, please contact:
Name: Eastern Health Office of Research and Ethics
Position: Manager
Telephone: 03 9895 3398
Email: ethics@easternhealth.org.au
Western Health (Footscray and Sunshine Hospitals):
For matters relating to research at the site at which you are participating, and if you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then the details of the local site complaints person are:Name: Mr Bill Karanatsios
Position: Research Program Director, Western Health Office for Research
Telephone: (03) 8395 8073
Email: ethics@wh.org.au
Tasmania
Sponsor Name: The Research Institute of the McGill University Health Centre
Website: https://rimuhc.ca/infectious-diseases-and-immunity-in-global-health-program
For any complaints concerning the conduct of the study at your treating centre in Canada, please refer to the contact information on your consent form.
Reviewing Human Research Ethics Committee:
Name: Health and Disability Ethics Committee
Telephone: 0800 4 ETHICS
Email: hdecs@health.govt.nz
Sponsor:
Middlemore Clinical Trials: Grants Manager
Email: grants@mmclintrials.nz
SNAP Trial Management Group:
Telephone:+61 3 8344 2554
Email: snap-trial@unimelb.edu.au
Hospital Research Governance Office:
Click on your region here for further information.
If you have questions about this research study or in case of any injuries during the course of this study, you may contact the site Principal Investigators:
Tan Tock Seng Hospital
Prof David Lye
National Centre for Infectious Diseases, Tan Tock Seng Hospital
Tel: 6357 7457 (office) / 9006 6785 (mobile)
Email: David_Lye@ncid.sg
National University Hospital
A/Prof Sophia Archuleta
Division of Infectious Diseases, National University Hospital
Tel: 6772 2002 (office) / 8186 9626 (mobile)
Email: sophia@nus.edu.sg
If you have any complaints about this research study, you may contact the site Principal Investigator or the NHG Domain Specific Review Board Secretariat at 6471 3266.
If you follow the directions of the doctors in charge of this study and you are physically harmed due to the antibiotics or procedures given under the study plan, the hospital’s clinical trial compensation scheme will pay the medical expenses for the treatment of that injury. Tan Tock Seng Hospital or National University Hospital without legal commitment will compensate you for the injuries arising from your study participation without you having to prove the hospital is at fault. There are however conditions and limitations to the extent of compensation provided. You may wish to discuss this with the site Principal Investigator. By signing this consent form, you will not waive any of your legal rights or release the parties involved in this study from liability for negligence.
Singapore General Hospital
Dr Shirin Kalimuddin
Department of Infectious Diseases, Singapore General Hospital
Tel: 6576 7763(office) / 8125 7493 (mobile)
Email: shirin.kalimuddin@singhealth.com.sg
If you have any complaints about this research study, you may contact the site Principal Investigator or the SingHealth Centralised Institutional Review Board at 6323 7515.
If you follow the directions of the Principal Investigator of this research study and you are injured due to the study drug or procedure given under the plan for the research study, our institution will provide you with the appropriate medical treatment. Payment for management of the normally expected consequences of your treatment will not be provided by Singapore General Hospital. You still have all your legal rights. Nothing said here about treatment or compensation in anyway alters your right to recover damages where you can prove negligence.
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You will be given a participant card with the study team details to keep with you at all times, and you will be able to use the contact details to contact the study team at any time if you have any questions or concerns.
Almost all of the results collected during your time on this study will be from tests that would have been done even if you were not in the trial. The hospital staff will record results from your routine tests and observations while you are in hospital (for example blood tests, temperature, symptoms, treatments). You will also be monitored for any side effects.
As part of the study, we will also collect samples of bacteria grown from your blood cultures. These will be stored and sent to a central laboratory for analysis. The results from these will help researchers better understand why infections with particular types of S. aureus respond differently to the antibiotic treatments.
When patients are unwell with an infection, blood samples are often taken to try to culture or grow germs from the blood. Blood is usually sterile, so the growth of a germ is an indication there is an infection in the body caused by that germ. If a Staph aureus is grown, then we call this a Staph aureus bloodstream infection. Patients with Staph aureus bloodstream infections are notified to the SNAP study team for consideration for the SNAP trial.
As part of standard clinical care, after identifying Staph aureus from the bloodstream, the bacterial isolate is further grown on culture media in the laboratory to allow testing for antibiotic susceptibility. The bacterial isolate is then usually frozen by the local laboratory in case further testing is required in the future. To help us better understand if there are factors associated with the Staph aureus isolate and outcomes from the bloodstream infection, we will be storing and then analysing these Staph aureus isolates. The Staph aureus isolates will be indefinitely stored at the University of Melbourne.
Analyses may include determining the susceptibility against different antibiotics, the kinds of toxins and proteins the isolate produces, and the DNA sequence of the isolate. The stored bacterial isolate does not contain any human tissue and is not considered to be a human biospecimen according to the National Health & Medical Research Council (NHMRC National Statement Chapter 3.2; National Statement on Ethical Conduct in Human Research 2007 [Updated 2018]; Chapter 3.2, page 47).
In some regions, this research project involves the collection of information about the participant's use of drugs. This information will be stored in a re-indentifiable (or coded) format. In the event that the hospital that enrolled you in the SNAP Trial is required to disclose that information, it may be used against you in legal proceedings or otherwise.
Data Linkage
We will also ask your permission to link your study information to existing datasets, such as hospital records, medications, emergency department, and registries of births, deaths and marriages, to allow longer follow-up.
Registry
As part of the study, we will also collect data for a registry of patients with S. aureus bloodstream infection. The registry will be used to improve current practice and quality of care.
All of the information collected as part of the Registry is from data that is routinely collected as part of your routine care and will be collected from your medical notes.
PET/CT Domain
If you are participating in the PET/CT domain and receive a PET/CT scan, we will also store the scan images in a secure central repository so they can be used for future research relating to this project or other closely related projects.
These images will be assigned a unique identifying code, but not your name or other individually identifiable information. They may be used with information from other sources outside typical clinical research settings (e.g., from public research databases), however, they will not be combined with other information in a way that could identify you.
Any future use of these images outside of projects related to Staphylococcus aureus and infections will be approved by a research ethics committee first.
In Australia, the PET/CT scan images will be stored in a secure database maintained by the Australiasian Radiopharmacuetical Trials network (ARTnet), located in Western Australia. You may request that your stored images be destroyed at any time by contacting the SNAP team (snap-trial@unimelb.edu.au).
For more information about ARTnet, please click here.
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Any identifiable information that is collected about you in connection with this study will remain confidential and will comply with all relevant country specific privacy legislation. If required, the regulatory authorities and an authorised representative of the trial Sponsor may require access to your personal information to ensure the clinical trial is compliant with the regulatory and safety requirements. The length of storage for identifiers and privacy legislations varies from country to country as indicated below:
Following study close out and locking of the database, data will be stored on the servers of the University of Melbourne. All analyses performed and the final data set will be archived together according to the University standard operating procedures. These records will be kept for a minimum of 15 years after the completion of the trial before being destroyed or erased, as per the National Health and Medical Research Councils guidelines. For further information on Australian clinical trials legislation, regulation and guidelines including the Commonwealth privacy Act (1988) please click here.
All identifiable data will be kept within your treating centre. Only de-identified data will be shared with international investigators which contains only a study code number in place of your name. Following study close out and locking of the database, data will be stored on the servers of the University of Melbourne. All analyses performed and the final data set will be archived together according to their university standard operating procedures. These records will be kept for a minimum of 15 years after the completion of the trial before being destroyed or erased, as per the Australian National Health and Medical Research Councils guidelines. In Canada, the McGill University Health Centre will receive a copy of the Canadian patient data which will be maintained for 25 years in accordance with Health Canada requirements. The separate database which links your name to your study code will be maintained at each participating centre for up to 25 years as per Health Canada requirements.
Following study close out and locking of the database, data will be stored on the servers of the University of Melbourne. All analyses performed and the final data set will be archived together according to the University standard operating procedures. These records will be kept for a minimum of 10 years after the completion of the trial before being destroyed or erased, as per the Medsafe and Ministry of Health guidelines. For further information on New Zealand clinical trials legislation, regulation and guidelines please click here.
Your participation in this study will involve the collection of “Personal Data”. “Personal Data” means data about you which makes you identifiable (i) from such data or (ii) from that data and other information which an organisation has or likely to have access. This includes medical conditions, medications, investigations and treatment history. Any biological samples and/or information containing your “Personal Data” that is collected for the purposes described in this Informed Consent Form will be stored in Singapore. Only anonymised (coded/de-identified) biological samples and/or data will be transferred out of Singapore to the University of Melbourne, Australia. By signing the consent form, you agree to the study team doctor and relevant research staffs collecting and using personal information about you for the research study. Any information obtained in connection with this research study that can identify you will remain confidential. It will only be used for the study or for future research related to S. aureus infections and related conditions. Your hospital will use your personal information as required for your care, to collect accurate data for the study, and if necessary to contact you about the study. If you withdraw your consent to take part in the study, your hospital will not collect any further information about you for the purpose of the study but will keep the information already collected solely for the purpose of the study. To safeguard your rights, your hospital will collect and use as little personal information as possible. In the event of any publication regarding this study, your identity will remain confidential. Your data will be stored in a platform that complies with IHiS security recommendation. Your personal information will never be made accessible to anyone outside of this research study team.
Your health records and any information obtained during the research study are subject to inspection for the purpose of verifying the procedures and data by the relevant authorities (NHG Domain Specific Review Board, Ministry of Health, Health Sciences Authority), the institution relevant to this participant information sheet (Tan Tock Seng Hospital, National University Health System [National University Hospital]), or as required by law. In addition, research arising in the future, based on your “Personal Data”, will be subject to review by the relevant Institutional Review Board. By signing the consent form, you authorise release of, or access to, this confidential information to the relevant study personnel and regulatory authorities as noted. At all times, all of the people involved in this study will have an obligation to keep the information about you as a research participant confidential and your data will be protected as confidential by law. If any information about this study is published or presented, your identity will remain confidential.
By participating in this research study, you are confirming that you have read, understood and consent to the Personal Data Protection Notification available at:
Tan Tock Seng Hospital
https://www.ttsh.com.sg/Patients-and-Visitors/Your-Hospital-Stay/Pages/Patients-Rights.aspx
National University Health System (National University Hospital)
https://www.nuh.com.sg/Pages/Personal-Data-Protection-Act.aspx
Hard copies are also available on request.
The regular blood tests obtained in this study will be analysed only for the purpose of this study and it will not be stored for future research. No incidental findings are expected to arise from the blood tests as they are standard laboratory investigations routinely ordered by hospital doctors and they do not involve any genetic testing. Incidental findings are findings that have potential health or reproductive importance to research participants like you/your child and are discovered in the course of conducting the study, but are unrelated to the purposes, objectives or variables of the study. These findings may affect your current or future life and/or health insurance coverage.
The S.aureus bacteria grown from your blood culture will be stored indefinitely in a sample bank located in the University of Melbourne, Australia. Studies on the cultured S. aureus bacteria will help researchers better understand how the bacteria make people sick and how the bacteria respond to antibiotic treatment. The stored bacteria will not contain any identifiable information that can be directly linked to you (that is, it will be coded/de-identified).This aspect of the research will not have any direct impact on you or your current treatment. No other biological samples (e.g., blood or urine) will be collected or stored for this study.
The biological samples collected for the study will be deemed to be gifted to Tan Tock Seng Hospital or National University Hospital and will not be returned to you. You will also not have any right or claim to any share in the commercial gain derived from the research (if any). However, you retain your right to ask the Principal Investigator to discard or destroy any remaining samples if the biological sample(s) is individually-identifiable and has not been used for the research or it has been used for research but it is practicable to discontinue further use of the biological sample(s) for the research.
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SNAP is a trial that adapts as we proceed. Once one treatment is found to be clearly better than another treatment, patients will continue to receive the better treatment and the poorer treatment is removed from the trial. With many hospital trial sites around the world, we should be able to recruit patients rapidly and allow us to reach appropriate conclusions as quickly as possible. As data accumulates, trial statisticians will analyse the data in near real-time. An independent data and safety monitoring committee will be reviewing these analyses to ensure patient safety is maintained and that results are acted upon in a timely and appropriate manner.
The advantages over other trial designs is:
the trial is continuous
as new interventions/treatments become available they can be added into the trial for comparison to current treatments
multiple questions can be answered simultaneously
answers to questions can be concluded when sufficient data have accrued, not when a specific sample size is met
the information collected from patients already participating in the study can be used to help guide the treatment of new patients joining the study
Interactions between interventions in different domains can be evaluated
With an adaptive design, existing patients can help guide treatment of new patients. Regular data analysis timepoints are built into the trial and interventions will be changed if during the analyses, an intervention is shown to be either:
Much better (continue with this intervention)
Currently no difference (continue with interventions until a difference is found)
Not as effective (stop this intervention)
If a new intervention becomes available include the intervention into the study
If you would like to find out more information about adaptive clinical trials please watch the videos below.
Learn more about why we’re studying treatments for S. aureus bloodstream infections in the SNAP trial.
Learn more about why we’re studying treatments for S. aureus bloodstream infections in the SNAP trial.
