As of February, 421 subjects have been enrolled in the EVADE study, of which 341 have been screen failed and 75 randomized.
Currently, there are 60 active sites in the following European countries: Austria, Belgium, Croatia, Czech Republic, France, Greece, Hungary, Israel, Portugal, Spain and Turkey. Additionally, through collaboration with the Antibiotics Resistance Leaders Group (ARLG), part of the Duke Clinical Research Institute, the first 2 sites in the US have been activated, and 12 additional sites are in start-up. 47 of these 61 sites have actively screened at least 1 patient and 27 have randomized at least 1 patient. Congratulations go to Dr Diehl’s site (Hôpital Européen Georges Pompidou, Paris, France) who have recently successfully randomized their first patient.
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 MedImmune/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 MedImmune (the global biologics research and development arm of 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.