Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects
SAATELLITE is a Phase II, randomized, double-blind, placebo-controlled trial. Involving patients who are at high risk of developing ventilator-associated pneumonia in an intensive-care unit. The trial will test the safety, the pharmacokinetic and pharmacodynamic characteristics, and the efficacy of MEDI4893. A novel treatment that uses antibodies against S. aureus.
The power of antibodies
MEDI4893, developed by MedImmune, the global biologics research and development arm of AstraZeneca, is a promising monoclonal antibody against S. aureus alpha toxin. The toxin kills cells in patients and damages tissues and organs, which helps microbes to spread and cause serious infections and disease. MEDI4893 uses an antibody – not an antibiotic – against this alpha toxin. Prevention would work against S. aureus, regardless of whether this bug is resistant to antibiotics. Another benefit is that this antibody approach is not expected to lead to new antibiotic resistance.
The study will test MEDI4893 in approximately 450 adult patients, in 60 to 80 ICUs across Europe. Patients in intensive-care units who need mechanical ventilation will be tested for the presence of S. aureus in their lower airways before they have developed a full-fledged infection and pneumonia. If they test positive, they will receive a single intravenous dose of MEDI4893 antibody. Which protects them from developing pneumonia.
Study team members
Contract Manager / Academic / Centre Hospitalier Universitaire de Limoges
Principal Scientist / EFPIA / MedImmune
Principal Investigator / Academic leader / Centre Hospitalier Universitaire de Limoges
Study level information
- Study NO NCT02296320
- Study Name SAATELLITE
- Study Type Phase II
- Study Status Recruitment Complete
- Enrollment Period 10/14 - 12/18
- Total subjects planned 285
- Total subjects screened 767
- Total subjects enrolled 213
- Total subjects completed 118
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- Preparation phase
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- Trial period
Country level information