Bacterial Sepsis Blood profiles
Research type
Research Study
Full title
A pilot study exploring the immune signature of Gram+ bacterial infections in the bloodstream of septic patients
IRAS ID
269597
Contact name
Tom Jaconelli
Contact email
Sponsor organisation
York Teaching Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
000, 000
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
we will to test blood samples from patients admitted to York hospital’s Emergency Department with suspected sepsis to try to identify patterns which could reveal the type of bacterial infection. The aim is to determine whether we can differentiate different types of infection causing sepsis and identify new diagnostic/prognostic biomarkers which could help in the selection of future treatments and antibiotic therapies, avoiding the use of broad spectrum antibiotics. [COVID-19 amendment 29/04/2020.] Due to the COVID-19 pandemic it has not been possible to continue to recruit patients into this study via the Emergency Department. Clinical teams have been prioritised to the treatment of COVID patients and unfortunately this means staff are unable to consent patients for other research studies. As such, we wish to temporarily suspend the Sepsis aspects of this study and instead refocus the same science and resource towards investigating the\nimmune response being seen in COVID patients. A funding application will be made to MRC for any additional costs, however this amendment is being submitted to REC/HRA now in order to minimise delay to implementation and to ensure that the recruitment process is clarified and approved prior to furthering discussions with participating clinical sites.\nAccumulating evidence suggests that a systemic cytokines storm is an important cause of death in patients with severe COVID-19 infection. However, evidence for laboratory features of a full cytokines storm syndrome as seen with other severe respiratory infections are not yet compelling and that brings concerns regarding the benefit of immunosupppresive treatments.\nWe seek permission to add a sub study to this existing study to ascertain the relationship between cytokines, chemokine and miRNA, their circulation patterns as indication of a cytokine storm, and the unusual high mortality rate seen with COVID-19. Outcomes would benefit the management of the outbreak as these biomarkers can be measured by simple immunoassays on small blood samples and could be considered for diagnosis at point of\ncare. It is also hoped to add value to the other interventional studies ongoing in UK hospitals such as RECOVERY, PRINCIPLE and REDMAP-CAP by contributing our data for patients enrolled in these studies. We propose a multi-site cohort sub-study, centred in Yorkshire and Humber (for logistical ease and to limit transport\nor travel). After lengthy discussions with research teams, clinical ICU teams, ward staff and laboratory technicians, we seek permission to incorporate the COVID aspects of this study into normal clinical care to minimise burden for clinical staff, deviation from normal care (be that standard care, trial treatment or other) and to avoid the overuse of very limited PPE stocks by research staff seeking consent.\nWe are seeking permission from the REC for an amendment to allow the research team to use either residual blood samples that remain following normal clinical processing, or where Sites don’t feel they would have sufficient residual sample (1.5 ml), to collect an additional 3ml samples from patients alongside their normal clinical samples. We have given very serious consideration to the justification and reasonableness of obtaining samples without\npatient consent and sought assurances that the confidentiality of donors and their associated health information is maintained at all times. Samples would be processed by hospital laboratories and provided to the research team anonymously. Any clinical data will be collated by clinical teams and provided to the research team linked to sample but non-identifiable.\nWe also seek permission to change to CI temporarily from Dr Tom Jaconelli (ED consultant) to Dr David Yates (Consultant in Anaesthesia and Intensive Care Medicine) in response to the change in focus on COVID-19 patients.This proposal has been critiqued by senior academic colleagues and by a wider team of clinical and research staff both within and external to the sponsoring organisation. It is likely that further investigators will be added to the study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0394
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion