Validation of a point of care technology for infection and treatment

• Research type

  Research Study

• Full title

  Validation of a point of care testing technology for bacterial infection and antibiotic sensitivities in a range of human fluid samples.

• IRAS ID

  304498

• Contact name

  Anna Rebecca Radford

• Contact email

  anna.radford@nhs.net

• Sponsor organisation

  Hull University Teaching Hospitals NHS Trust

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Infections are a common presentation within a hospital setting, e.g. urinary tract infections (UTI) accounting for 19.7% of all hospital acquired admissions) or due to treatment provided in hospital such joint replacement infections (1-2 % of knee and hip replacements). All can be associated with significant morbidity and mortality. Infections are associated with significant cost to the NHS each year; £434 million was spent in 2013/14 treating 184,000 unplanned admissions due to UTI. Often broad-spectrum antibiotics are prescribed whilst awaiting formal culture results, which may be negative or demonstrate resistant organisms to the initial treatment. Increasingly antibiotic microbial resistance is emerging as a global threat to all life on this planet. Appropriate use and targeted selection of antibiotics should be the aim of all healthcare professionals.
  U treat® is a available to treat UTIs in companion animals and has shown promising results in a very small adult human trial. However, this system has not been used in hospital adult patients, nor children, and only with urine.
  We hope to perform a validation study, over a maximum of 1 year in the following three NHS establishment: Hull University NHS Trust, James Cook Hospital Middlesbrough and Leeds University Teaching Hospitals NHS Trust. Samples will be sent to a University of York laboratory for independent assessment in the Medical Engineering Department. The areas we hope to demonstrate proof of concept in are:
  1) Urinary tract infection identification in a hospital setting within a paediatric population.
  2) Periprosthetic joint infection in adults and primary joint infection in children using synovial fluid.
  3) Ventriculo-peritoneal shunt infection

  The results for the technology within the U Treat device will be compared to hospital laboratory tests but will not alter the patients care at all. Data obtained will not be for commercial benefit but lead to further, separate studies with appropriate permissions.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0108

• Date of REC Opinion

  20 Jul 2022

• REC opinion

  Further Information Favourable Opinion