Use of Multiplex PCR in diagnosis of Native joint Infection

• Research type

  Research Study

• Full title

  Use of Multiplex PCR in the diagnosis of Native joint infection in a point of care setting

• IRAS ID

  221056

• Contact name

  Mike reed

• Contact email

  mike.reed@nhs.net

• Sponsor organisation

  Northumbria Healthcare NHS Foundation Trust

• Clinicaltrials.gov Identifier

  221056/1064329/20/731, NIHR CRN Portfolio

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Why?

  Septic Arthiritis represents a medical emergency. Its timely and accurate diagnosis is vital to ensure patients have a good outcome. Any delay in this diagnostic step can result in significant morbidity and mortality. The current method for investigating these patients includes; clinic examination, radiology investigations including plain xray, Bloods ( inflammatory profile), and the gold standard, arthrocentesis (sample of joint fluid). This fluid is then sent for gram stain and culture. Gram stain and microscopy is entirely operator dependant and can lead to false positives/ Negatives. Furthermore time taken for results to be available from culture can vary between 1 day and 14 days. All of which adds to delay and uncertainty in diagnosis. We hypothesis that Multiplex PCR will give us an accurate and, crucially, a prompt diagnosis of NJI and organism.

  What?
  This study will look specificically at patients with query Native joint infection. It will analyse the sensitivity and specificity of the Unyvero Cureitis i60 V2 cartridge against our standard practise of gram stain and culture.

  Who?
  Any patient who presents to the Northumbria Healthcare trust with query native joint infection will be eligible to participate within the study. Exclusions would include children defined as those below the aged of 16.

  Where?
  The study will recruit entirely at the Northumbria specialist emergency care hospital and represents a single site study.

  How?
  We expect the study to run for 12 months. We aim to recruit 100 patients. Patients will have joint aspiration performed as per routine for the work up of someone investigated for septic arthritis. The sample will be split, half sent for routine gram stain, microscopy and culture. The other half will be analysed using the multiplex PCR system.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  17/WM/0139

• Date of REC Opinion

  19 May 2017

• REC opinion

  Further Information Favourable Opinion