ECUSTEC
Research type
Research Study
Full title
Eculizumab in Shiga-Toxin producing E. Coli Haemolytic Uraemic Syndrome (ECUSTEC): A Randomised, Double-Blind, Placebo-Controlled Trial
IRAS ID
199217
Contact name
Sally Johnson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2016-000997-39
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
Shiga Toxin producing Escherichia Coli (STEC) Haemolytic Uraemic Syndrome (HUS) (STEC HUS) follows a gut infection with Shiga-toxin producing E. coli, which causes severe (often bloody) diarrhoea. Around 1000 UK children are infected with STEC each year and ~100 of these develop STEC HUS when a toxin from STEC causes damage to small blood vessels, especially in the kidneys. About 50-60% of children with STEC HUS need dialysis (artificial kidney support) which may last several weeks. About 2-3% of children with STEC HUS die and about 20-25% get HUS in their brain, causing fits or a stroke. Many make a full recovery, but about 25-30% will have permanent kidney damage or more rarely brain damage. Eculizumab is a drug which blocks part of the immune system called complement. Evidence suggests complement plays a role in STEC HUS, evidence also suggests eculizumab is very effective in a related condition - atypical HUS. The ECUSTEC study aims to see if eculizumab really does make STEC HUS better. 134 children with STEC HUS will be recruited from children’s kidney units around the UK. They will receive either eculizumab or placebo (inactive medicine) soon after arriving at the unit and a 2nd dose of the same medicine a week later. For each child we will assess how severely STEC HUS affected them (including how long they needed dialysis, any stomach operations, any heart or brain damage) and turn this into a score (severity score). Mild cases will have a low score and severe cases will have a high score. We will compare the severity score in those who received eculizumab and those who received placebo to see whether eculizumab reduces the severity of STEC HUS and by how much.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0325
Date of REC Opinion
5 Dec 2016
REC opinion
Further Information Favourable Opinion