TIssue Models for Invasive Disease (TIMID)
Research type
Research Study
Full title
TIssue Models for Invasive Disease (TIMID)
IRAS ID
219992
Contact name
Marco Rinaldo Oggioni
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
RM38G0091, Leicester grant costing code
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The human immune response to bacterial blood stream infection (sepsis) are fairly well understood, but we lack details on the most early phases. Better knowledge of these events would be important for the prevention and treatment of severe bacterial disease. From models of infection, we have data showing that bacteria replicate in a specific type of cells in the spleen from where the bacteria then seed to the blood to cause blood stream infection. In order to gain more relevant data for humans, we have developed a spleen perfusion model using pig organs. This model confirms our previous work and most importantly will now allow us to study these events in human organs. In order to move novel treatment strategies into human trials, we propose to test early events during infection using human spleens and the cells and tissues derived thereof. This research is expected to provide data on the relevance of the early events in bacterial disease, in particular on the role of immune cells. The research includes work with human cells and tissue obtained from human spleens. In these settings, we will test pharmacological prevention and treatment of severe bacterial infection (sepsis). The expected outcome of this work on human organs and tissue is expected to provide evidence that allows to move new treatment options into clinical trial. [COVID-19 amendment 18/05/2020] Request to include COVID-19 research into the trial protocol and extension of the end date. The primary objective of the study is to identify therapies acting on the initial events during invasive bacterial infection by working ex vivo on spleens removed during surgery for partial pancreatectomy. In view of the COVID-19 situation and the relevance of our ex vivo model for COVID-19 infection we request to extend the scope of the study from “bacterial infections” to “bacterial and viral infections”. This change was performed throughout the protocol (33 in-text revisions throughout the protocol). We also request that the end date of the project would be moved by one year to the 28/02/2022, as our recruiting has stopped due to the COVID crisis and University closure.\n
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0057
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion