Mass Code Project

Can rapid integrated Polymerase Chain Reaction (PCR)-based diagnostics for gastrointestinal pathogens and direct sequence typing of Clostridium difficile from stool improve routine Hospital Infection Control practice?

Many patients have diarrhoea at or during admission to hospital. Hospital staff  need to work out quickly which patients have infectious diarrhoea because the patients who really are infectious need to be put in single (or side) rooms so they don’t pass bugs onto other patients. This is important because many UK hospitals have a limited number of side-rooms: patients who really are infectious cannot get a side room if these rooms are already occupied by patients who turn out to not be infectious. The problem is that currently used tests are labour intensive and there is no single test which can identify the cause of a case of diarrhoea. Instead lots of different tests have to be run in parallel. It is only possible to be reasonably certain that a patient’s diarrhoea isn’t infectious when the last test is completed – this can take 1-3 days. The development of MassTag multiplex PCR, which can detect up to 30 pathogens in a single lab test in 3-4 hrs, potentially offers a cost effective and rapid way to find whether or not the patient really has C.difficile and other common gastrointestinal bugs. If successful, the use of this test could free up single rooms that are currently used to isolate patients with suspected infectious diarrhoea that isn’t subsequently confirmed as being infectious by current tests. It could also mean that patients get more appropriate treatment faster – and that patients who don’t have infectious diarrhoea are not given drugs unnecessarily.

This study is funded by the National Institutes of Health Research Health Technology Assessment programme to look at this issue. It is a two-stage diagnostic test study that will run for 3 years within two NHS Trusts (Oxford University Hospitals NHS Trust and the Leeds Teaching Hospitals NHS Trust). Remaining material from stool (poo) samples sent for testing to the labs from patients in these hospitals will be used in this study. All the normal tests will be done first and patients will be managed using results from these tests - so there is no impact on their clinical management and the patients are not identified in our study. Stage I will test fixed numbers of samples which we already know from the lab testing are either positive or negative for 4 important bugs - C. difficile, Campylobacter spp., Salmonella spp. and Norovirus. This will let us work out how accurate the new MassTag test is compared to routine testing. Stage II will test the same poo samples from patients admitted to general medicine and surgery in Oxford and Leeds hospitals by both routine testing and the MassTag system in real-time – in this bit of the study we won’t already know which samples contain which bug. This will let us work out if the new test is accurate enough to use in NHS labs and also how much time it would save. Health economists in Oxford are also looking at the costs of testing these samples and how the MassTag  test may impact on patient pathways. This will allow us to work out how much the new system will cost or save the NHS, how it will impact on the use of side-rooms, and whether it will allow us to more quickly identify outbreaks of infectious disease.

Staff Members

Oxford

• Chief Investigator -  Prof Derrick Crook, Consultant Clinical Microbiologist, OUH Trust
• Principal Investigator - Prof Timothy Peto, Consultant Infectious Diseases, OUH Trust
• Project Manager - Jaim Sutton, Microbiology, University of Oxford
• Statistician - Dr Sarah Walker, Microbiology, OUH Trust
• Senior Laboratory Scientist - Dr Kate Dingle, Microbiology, University of Oxford
• Senior Infection Control Manager - Lily O'Connor, Microbiology, OUH Trust
• Postdoctoral Researcher - Dr Louise Pankhurst, Microbiology, University of Oxford
• Research Assistant - Jessica Evans, Microbiology, University of Oxford
• Health Economist - Prof Alastair Gray, Health Economics Research Centre, University of Oxford
• Health Economics Research Assistant - James Buchanan, Health Economics Research Centre, University of Oxford

Leeds

• Principal Investigator - Prof Mark Wilcox, Consultant Medical Microbiology, University of Leeds
• Scientist - Kirsti Morris, University of Leeds 
• Research Nurse - Faye Pinker, University of Leeds   

Collaborators

• Agilent
• Xynostics 

Ethics 

Funder

NIHR Health Technology Assessment programme

Sponsor 

Oxford University Hospitals Trust, John Radcliffe Hospital, Headley Way, Oxford, OX9 3DU