AdVance
Research type
Research Study
Full title
Incidence and outcomes associated with the management of adenovirus infections in allogeneic hematopoietic cell transplant recipients: AdVance https://www.harp.org.uk/Member/Applications/Edit/352405#ProjectDetails
IRAS ID
215567
Contact name
Robert Wynn
Contact email
Sponsor organisation
LASER
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Haematopoietic stem cell transplantation (HCT), also known as blood and marrow
transplantation, is used to treat a wide range of malignant and non-malignant blood-related and immune system disorders. Allogeneic haematopoietic stem cell transplantation (allo- HCT) involves replacing the bone marrow stem cells of a patient following high-dose therapy with stem cells from a donor.
Adenovirus infection is an extremely serious condition with severe consequences in patients who undergo allo-HCT. It is predominantly happened in paediatric patients, although adults with affected immune system are also at risk. Disease progression can be rapidly fatal without immediate intervention, and mortality rates are reported as high as 80% untreated.
Despite the consensus of opinion regarding the high risk of death with adenoviral infection, there is a lack of consistent, multi-centre data on standards of care, disease course and overall outcomes in patients with adenovirus following allo-HCT.
The overall aim of the study is to describe the incidence, outcomes and standards of care of adenovirus infections and associated practice patterns in allo-HCT recipients in European countries.
This is a retrospective observational (non-interventional) study, and as such there is no investigational product or procedure being administered. The study will be retrospectively reviewing pre-existing patient charts (from 1st January 2013 to 30th September 2015) for information on diagnosis and treatment of allo-HCT patients with adenovirus infection.
The source population will comprise of paediatric and adult allo-HCT recipients at participating transplant centres during the pre-specified study period. Approximately 20
paediatric, 10 adult and 20 mixed (adult and paediatric) centres performing allo-HCT across five countries (UK, France, Spain, Germany and Italy) will be considered.
This will represent an important advance in understanding the disease and its management, having a significant public health importance considering a very high mortality.
The study is funded by Chimerix, Inc and conducted by LA-SER Europe.REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/2104
Date of REC Opinion
24 Nov 2016
REC opinion
Further Information Favourable Opinion