Dose Assessment of Melatonin in Sepsis Trial

Summary

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.

Timeline

Start

2017-04

Primary completion

2019-06

Completion

2019-12

Outcome

Outcome not reported

Stopped: “Study registered elsewhere and is not covered by FDA”

Drugs

Indications