Enhanced, deployable, antibiotic stewardship and diagnostic capability using the MeMed BV® assay
What does the study involve
This study is looking to see how accurate a new device is at telling the difference between a bacterial and viral infection. It uses a small blood sample which is analysed and gives the results rapidly so a decision can be made about treatment. In studies so far, the device has demonstrated its ability to correctly detect a bacterial infection nine times out of 10 and to rule out a bacterial infection 19 times out of 20. This is far better than any of the clinical decision-making tools we use currently.
Why do we need to do the study
Antibiotics are one of our greatest assets in the fight against infection. However, rising resistance to them means they should be used only when necessary. Most infections we see in primary care are caused by viruses. They will settle on their own end, although you may feel unwell for a few days, you should make a full recovery. This is the same for most bacterial infections although some do need antibiotics in order to help recovery or prevent admission to hospital. We currently rely on taking a history, examination, and using certain calculators to predict the risk of a bacterial infection. We can do blood tests and swabs, but these usually take a minimum of 24 hours to be made available (48 hours in the case of a swab) so do not assist with the immediate decision to prescribe antibiotics or not. It is hoped this machine will make the accuracy of our diagnosis even better by providing a rapid test to differentiate between a virus and a bacteria. It does this by looking at certain markers in the blood. It will therefore result in more appropriate prescribing.
It is planned that the device will be used in the firm base (in a Medical Centre such as the QEMHC MRS) for both service personnel and their dependents, or when the service person is deployed on operations.
What will the study entail?
When you come to the medical centre, the care and clinical management you have will not change. If you are happy to consent, a sample of blood will be drawn and either a throat swab or a sample of sputum taken. This will then be sent to Porton down for analysis, both in the test machine and another analyser which represents the gold standard. We will not have the results and your treatment will not change. In other words, if the decision is made between you and the healthcare professional to wait-and-see, this will take place. If a deferred prescription for antibiotics or an immediate prescription is decided upon, this too will take place. We in the QEMHC MRS will be blinded to the results (we won’t know what the test showed). This is important so that bias is not introduced into the analysis.
What conditions will the study look at?
For this evaluation, we are interested in infections of the respiratory system. The two conditions are an upper respiratory tract infection (usually a sore throat but can include tonsillitis) and a lower respiratory tract infection (not a pneumonia, but a condition where you have a cough, fever, and are coughing up sputum). The exact inclusion criteria have yet to be determined but it is likely that you if you present to the medical centre with any of the above within 7 days of the start of symptoms, you will be offered chance to take part in the trial.
What about consent?
If you are offered a chance to take part in the trial, this will be done prior to taking any samples. You’ll be able to read the patient information leaflet after which the decision to continue with the enrollment into the trial is entirely yours. There will be absolutely no pressure or coercion for you to take part. If you initially consent to the trial but later change your mind, you can withdraw. Please be advised however that once the process of analysis of the sample(s) has been started, because of the anonymization process, we may not be able to pull your sample. To re-iterate, this study is completely anonymous as we are using your primary care record number (DMICP) to identify you.