‘Eculizumab in Shiga-Toxin producing E. Coli Haemolytic Uraemic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Trial’
This is a trial currently recruiting on the Paediatric Nephrology Unit at UHW
Aim of trial:
To assess whether Eculizumab reduces the severity of Shiga-toxin producing Ecoli Haemolytic Uraemic Syndrome (STEC HUS) in children and young people
What is Eculizumab?
Primary Research Objective:
To determine whether the severity of STEC HUS is less in those given Ecu compared with those given placebo, in children aged 6m-18 years
-Clinical Severity Score assigned at day 60
i)To assess the safety of Ecu in STEC HUS
ii)To determine whether the incidence of CKD following STEC HUS is less in those receiving Ecu compared with those receiving placebo
iii)To evaluate the cost-effectiveness of administration of Ecu in STEC HUS from the perspective of the NHS
Active arm: Standard therapy + 1st dose Ecu Day 1, & 2nd dose Ecu Day 8
Control arm: Standard therapy + 1st dose placebo Day 1, & 2nd dose placebo Day 8
NB: The trial contains an internal pilot phase of 18m (12m recruitment, 6m follow-up), the purpose of which is to determine whether the substantive trial will continue.
For further information please contact:
Jennifer Muller, Paediatric Research Specialist Nurse (CYARU)