ECUSTEC

Full Title: ECUlizumab in Shiga-Toxin producing Escherichia Coli Haemolytic Uraemic Syndrome (ECUSTEC): A Randomised,

Double-Blind, Placebo-Controlled Trial

Short Title: ECUSTEC

Aim of the Trial: To determine whether Eculizumab reduces the severity of Shiga-Toxin producing E. Coli Haemolytic Uraemic Syndrome (STEC-HUS) in children.                                               

Trial design: Randomised, parallel group, double blind, placebo-controlled trial

Sample size: 134

Trial Duration: 6 years

Trial Start/End Dates: 1st April 2016 - 31st March 2022

ECUSTEC Protocol V4.0 (18th January 2018)

ECUSTEC Online Randomisation and Data Entry

Contact the ECUSTEC Trial Team

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Further details...

Chief Investigator: Dr Sally Ann Johnson, The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Trial Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Funding: National Institute for Health Research Efficacy and Mechanism Evaluation (EME 14/48/43)

EudraCT Number: 2016-000997-39

MHRA CTA: 17136/0282/001-0001

Research Ethics Committee: North East - Newcastle & North Tyneside 1 Research Ethics Committee

REC Reference Number: 16/NE/0325

ISRCTN89553116

NIHR CRN Study ID:32199