The performance of the Mologic biomarker panel in infection

• Research type

  Research Study

• Full title

  An observational study to evaluate the diagnostic and predictive accuracy of the Mologic Biomarker Panel in patients with severe infection

• IRAS ID

  228171

• Contact name

  David Brealey

• Contact email

  d.brealey@nhs.net

• Sponsor organisation

  Mologic

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  There is no definitive way for a doctor to diagnose a patient has an infection. The diagnosis is essentially made in the same way as it has been for over one hundred years and though there are now some blood tests that can help, they are too non-specific to alter management. A more recent heightened awareness of 'sepsis' and the dangers of not treating has seen a marked rise in antibiotic use in the UK. This means many patients are being harmed by receiving unnecessary antibiotics and through the development of antibiotic resistance.

  The study proposed, is to examine a new test to help the doctor decide if the patient has an infection or not (and so does not need antibiotics). The study is observational and will look at how the test performs in 3 hospital populations being managed for potentially serious infection:
  1)Patients in the emergency department
  2)Deteriorating ward patients
  3)Patients on the Critical Care Unit
  Patients undergoing elective major surgery will act as a control group (they have a temperature etc. but they do not have an infection) to see if the test can delineate the difference between the symptoms of inflammation caused by surgical trauma and those caused by infection

  The study will involve sequential blood tests and the collection of clinical data. A panel of experts will then decide if the test is performing accurately, but also whether it could be of use in predicting outcome of the infection and success/failure of treatment. The study will have no impact on patient management.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  17/LO/1058

• Date of REC Opinion

  5 Jul 2017

• REC opinion

  Favourable Opinion