ECUSTEC

 

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

Important Message: COVID-19
We are now home-based during the COVID-19 pandemic but available and working. Responses may however take longer than normal as staff may be working altered hours but we are cross covering trials as required and urgent matters will be dealt with promptly. Please do not contact our usual office/landline number and instead email the trial contact and copy in the trial mailbox. If a query requires a prompt response please mark as ‘urgent’ in the email subject header.

Please be aware due to the COVID-19 outbreak recruitment to ECUSTEC is currently suspended until further notice

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