Study design
encephalitis
ENCEPHALITIS
IgNiTE was a randomised, double blinded, parallel arm, placebo-controlled study to compare early IVIG treatment with placebo in the treatment of childhood encephalitis in individuals aged 6 months to 16 years. It was conducted across 21 National Health Service (NHS) hospitals in the UK. Participants were followed up for 12 months after randomisation, with outcomes assessed during the acute admission, at 4–8 weeks after discharge from acute care, at 6 months after randomisation, and 12 months after randomisation.The trial was prospectively registered with ClinicalTrials.gov (identifier NCT 02308982) on 5 December 2014. The trial was assigned an International Standard Randomised Controlled Trial Number on 24 June 2015 (ISRCTN 15791925), and a European Clinical Trials Database number (2014-002997-35). A Trial Steering Committee (TSC) was established to oversee the trial, and an independent Data Monitoring and Ethics Committee was set up to monitor the safety, efficacy and overall conduct of the study.The original trial protocol was published on 3 November 2016.
