OASIS: Talactoferrin for treatment of Severe Sepsis
Research type
Research Study
Full title
OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis
IRAS ID
73348
Sponsor organisation
Agennix Incorporated
Eudract number
2010-023986-23
Clinicaltrials.gov Identifier
Research summary
Severe sepsis is when an infection results in impaired functioning of vital organs such as the brain, lungs, liver, heart and kidneys. This can be very serious and may lead to permanent health problems, or even death.Standard treatment involves antibioticsfluds and artificial organ support (e.g. drugs to maintain blood pressure, ventilator to support lungs). New treatments that can modulate the immune system potentially offer added benefit and outcome improvement. Talactoferrin is a recombinant human lactoferrin (produced by microbes) which is similar in structure and function to human lactoferrin. Previous studies have shown that lactoferrin can help kill bacteria and reduce inflammation. The purpose of this study is to determine how safe and effective a solution of talactoferrin is for improving survival and reducing the severity of severe sepsis. Patients will be randomly assigned to receive talactoferrin or placebo (dummy drug). In addition to standard care, they will receive a solution of study drug orally three times a day until they are discharged from the intensive care unit (ICU) or for up to 28 days.Patients will be monitored daily while in the ICU. Study visits will be performed on the day of study drug discontinuation, Day 28 and 28 days after study drug discontinuation. Study assessments include physical examination, vital signs and blood sampling. Patients will be followed for survival up to 12 months.Some patients will participate in a sub-study to look at the pharmacokinetic/pharmacodynamic/echocardiographic effects of talactoferrin in patients with severe sepsis. The will involve extra blood samples and echocardiograms.This study is sponsored by Agennix Incorporated. 350 patients will be enrolled and once the results have been reviewed, a decision will be taken on enrolling a further 930 patients. Patients from Europe, Israel and North America will participate with approximately 53 patients from 5 UK hospitals.
REC name
London - Harrow Research Ethics Committee
REC reference
11/LO/0355
Date of REC Opinion
27 May 2011
REC opinion
Further Information Favourable Opinion