DAMSEL 2 is a pilot Phase II study in patients with sepsis. Stage 1 will assess the
pharmacokinetics of melatonin and its major metabolite after a single dose of 50 or 100mg
exogenous melatonin in two small groups of patients with sepsis in order to make dosing and
dosing interval decisions for Stage 2.
Stage 2 is a double blind randomised controlled trial of melatonin in patients with sepsis at
the dose and dosing interval decided after Stage 1. Measurements of melatonin and its major
metabolite, and an array of biomarkers of inflammation and oxidative stress will be made,
plus transcriptome (mRNA) analysis. This study will inform a planned larger phase II trial.