Sepsis Clinical Trial
Official title:
Dose Assessment of Melatonin in Sepsis Trial
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.
Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation,
mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria
and both it and its metabolites have potent antioxidant and anti-inflammatory activity,
preventing organ dysfunction in a rat model of sepsis. In a recent Phase I dose escalation
study (DAMSEL 1) the investigators showed that oral doses of melatonin in healthy subjects
were well tolerated with no adverse events and resulted in levels of circulating melatonin
and its major metabolite which had beneficial anti-inflammatory and antioxidant actions in
ex vivo studiesStage 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.
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