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Contact Information:

Dr SNAP Study team
+44 20 7670 4817
mrcctu.snap@ucl.ac.uk


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Be Part of Research - Trial Details - Staphylococcus aureus Network Adaptive Platform trial (SNAP)
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Staphylococcus aureus Network Adaptive Platform trial (SNAP)

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Staphylococcus aureus bacteraemia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Bacteraemia is a dangerous condition occurring when bacteria enter someone’s blood (infection in the blood). Bacteria called Staphylococcus aureus (S. aureus) can cause S. aureus bacteraemia (SAB). Up to a third of people with SAB die within 3 months, even when treated with antibiotics. The aim of the research is to find out which treatments for this illness are best and if we can reduce the number of deaths from this disease.
The sort of questions we want to answer are:
1. What is the best main antibiotic treatment for S. aureus bacteraemia? This is being explored in a part of the trial (domain) called the 'backbone' (or main) antibiotic.
2. Would it be better to add an extra antibiotic to treat the condition? This domain is called Adjunctive (additional) antibiotic(s).
3. Once patients are feeling better do we need to continue antibiotics via a drip (usually in hospital) or could we give patients tablet antibiotics to take at home instead? This domain is called 'early oral switch' where some people are moved to tablet antibiotic(s) early.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Feb 2022 30 Jun 2027

To work out which medicine is best researchers use clinical trials called a randomised controlled trial (RCT). The treatments are chosen randomly (like the flip of a coin) and one person may receive more than one treatment. Some patients then receive one or more medicines, whilst other patients receive different treatment(s). This means the same patient can be in more than one part of the trial. In this trial the drugs used are already licensed drugs used around the world to treat patients with this disease.

This is an international adaptive study so the researchers analyse the results as the study goes on rather than just at the end. If the results show any of the treatments do not work as well as others, they will be removed from the study. Similarly, new arms may be added. The initial length of the trial is 4 and a half years. Each person would be in the trial for 3 months with their data collected & stored longer.


Patients infected with Staphylococcus aureus.

You can take part if:



You may not be able to take part if:


1. Time of anticipated platform entry is greater than 72 h post collection of the index blood culture2. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures, excluding those organisms judged to be contaminants by the treating clinicians3. 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, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)4. Known previous participation in SNAP5. Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 h and 180 days prior to the time of eligibility assessment6. Treating team deems enrolment in the study is not in the best interest of the patient7. Treating clinician believes that death is imminent and inevitable8. Patient is for end-of-life care and antibiotic treatment is considered not appropriate9. Patient <18 years of age and paediatric recruitment not approved at recruiting site10. Patient has died since the collection of the index blood culture


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Benefits:
Not provided at time of registration
Risks:
This trial is considered to be relatively low risk due to the fact that all of the interventions are already known treatments for S. aureus infections. No matter what arm participants are randomised to, they will be receiving treatments that are already licensed in the UK and known to be efficacious.
However, as with any medications, there are still risks, and there are a number of possible side effects in particular relation to antibiotic treatment. The PIS highlights that while risks are low with already licensed medications, these can still occur and outline some of the likely side effects. Where the combination of antibiotics may increase particular risks, this is highlighted in the PIS, and details are provided on the additional monitoring that will be undertaken as a result.
Data privacy poses another potential risk, however, this will be kept to a minimum through use of a secure database with tightly regulated access. Participant data will be pseudonymised before being entered into the study database, and this will only be viewable by the study site and the central trial and data managers. Any directly identifiable data will be restricted to the study site team, and to monitors to facilitate data checks.
Due to the severity of SAB, consent by the participant's authorised representative could also be a risk. In this situation the patient may have been consented to a study that they might not have consented to themselves. All patients will be approached to give their own consent as soon as feasibly possible in their recovery, and may withdraw their participation if they choose at any time in the trial.

Dr SNAP Study team
+44 20 7670 4817
mrcctu.snap@ucl.ac.uk



The study is sponsored by University College London and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN17997749

Or CPMS 58551

Last updated 04 October 2023

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