Patient Information Sheet (16–18 Years): Eculizumab in Shiga-Toxin Producing E. Coli Haemolytic Uraemic Syndrome (ECUSTEC) Randomised Double-Blind Placebo-Controlled Trial

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Information sheet for adolescents aged 16–18 outlining the design, purpose, procedures, risks, and follow-up of a UK-based randomised controlled clinical trial evaluating eculizumab for STEC HUS.

Trial Title: Eculizumab in Shiga-Toxin Producing E. Coli Haemolytic Uraemic Syndrome (ECUSTEC): A Randomised, Double-Blind, Placebo-Controlled Trial

Acronym: ECUSTEC

Type of Document: Patient Information Sheet

Study Design: Randomised, Double-Blind, Placebo-Controlled Trial

Medical Condition: Shiga-Toxin Producing E. Coli Haemolytic Uraemic Syndrome (STEC HUS)

Investigational Medicinal Product: Eculizumab

Comparator: Placebo

Target Population: Children and Young People Aged 16–18 Years Diagnosed with STEC HUS

Sample Size: 134 Participants

Geographical Scope: United Kingdom

Study Duration: Four Years Recruitment with 12 Months Follow-Up per Participant

Co-ordinating Centre: Birmingham Clinical Trials Unit (BCTU)

Intervention Schedule: Two Doses Within One Week, First Dose Within 48 Hours of Admission

Primary Objective: To Assess Whether Eculizumab Reduces Disease Severity in STEC HUS

Consent Requirement: Written Informed Consent Required

Voluntary Participation: Yes

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