Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically ventilated Subjects
EVADE is a Phase II, randomized, controlled safety and efficacy trial of MEDI3902. It is a bispecific monoclonal antibody against two Pseudomonas aeruginosa proteins, for the prevention of ventilator-associated pneumonia in adult ICU-patients. In collaboration with AstraZeneca, up to 120 ICUs will participate in this study.
Getting around P. aeruginosa
Pseudomonas aeruginosa is one of the most important pathogens for critically ill patients treated in intensive-care units (ICUs). It is intrinsically resistant to many antibiotics and has a remarkable capacity to acquire novel resistance mechanisms. Acquisition can occur either due to mutations under direct antibiotic pressure. Or through horizontal gene transfer of resistance genes. Especially threatening are carbapenem‐resistant variants of P. aeruginosa. The mechanisms and transmission pathways underlying the success of these clones are far from understood. Furthermore, P. aeruginosa has well‐characterized virulence factors, such as PsI and PcrV toxins.
Antibodies as prevention strategy
Historically there are a small number of new antibiotics in the pipeline to treat infections caused by multidrug resistant P. aeruginosa. Protection against virulence factors and toxins offers a novel potential infection prevention strategy. In fact, monoclonal antibodies are increasingly being tested as an adjuvant therapy for hospital‐acquired infections. Based on ground-breaking studies, the first antibody‐based therapeutic options for multidrug resistant P. aeruginosa infections have recently been clinically evaluated.
EVADE is a Phase II, randomized, controlled safety and efficacy trial of MEDI3902. In close collaboration with AstraZeneca, up to 120 ICUs across Europe will participate in this study. Aiming to assess the effectiveness of MEDI3902 as a preventive measure for P. aeruginosa infections. Especially of ventilator-associated pneumonia in adult ICU patients.
Study team members
Contract Manager / Academic / University Hospital Center of Limoges
Antoni Torres Marti
Principal Investigator / Academic co-lead / Hospital Clinic of Barcelona
EFPIA / MedImmune
Study level information
- Study NO NCT02696902
- Study Name EVADE
- Study Type Phase II
- Study Status Recruitment Complete
- Enrollment Period 03/16 - 10/19
- Total subjects planned 286
- Total subjects screened 1023
- Total subjects enrolled 188
- Total subjects completed 184
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- Preparation phase
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- Trial period
Country level information