SAATELLITE - Phase 2 study of MEDI4893 in mechanically ventilated pts
Research type
Research Study
Full title
A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects
IRAS ID
164654
Contact name
Hasan Jafri
Contact email
Sponsor organisation
MedImmune LLC
Eudract number
2014-001097-34
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Bacterial pneumonia occurring in patients in Intensive Care Unit (ICU) is a clinically significant and serious disease. It is the second leading type of hospital acquired infection, as well as the leading cause of death from hospital acquired infections. Staphylococcus aureus (S. aureus) is one of the most common bacteria and is the primary cause of hospital acquired pneumonia.
S aureus makes chemicals and proteins called toxins which cause injury to the body during an infection. One of the main toxins produced by S aureus is alpha toxin. The study medication, MEDI4893 is an antibody (an immune protein that may protect against infection) that acts against alpha toxins that S aureus makes. MEDI4893 has been designed to work for 1-2 months after a dose, and may be found in the body for up to a year after dosing.
The purpose of this study is to determine if MEDI4893 is safe and effective in preventing these infections in patients who are on a ventilator and at high risk of S aureus infections, but are currently free of S aureus related disease but have S aureus bacteria in their lower respiratory secretions.
Participants will receive a single intravenous infusion of either 2000mg MEDI4893, 5000mg MEDI4893 or placebo on Day 1. The treatment the patient will receive will be random, like rolling a dice. Participants will be followed up to Day 361. Procedures include: vital signs, physical examination, Chest X-ray, urine, blood and sputum samples for laboratory tests and questionnaires to monitor participant’s health and side effects of the drug.
This study is being sponsored by MedImmune who will perform the study in conjunction with COMBACTE – a consortium of researchers in the field of antibiotic resistant bacteria and ventilator associated and ICU pneumonia. Approximately 462 participants will take part in the study, with approximately 24 participants in the UK.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0099
Date of REC Opinion
4 Feb 2015
REC opinion
Favourable Opinion