As of today, 483 subjects have been enrolled in the EVADE study, of which 86 have been randomized. We have now reached steady state recruitment with 5 randomizations in March, and 4 in April.
Currently, there are 72 active sites in the following countries: Austria, Belgium, Croatia, Czech Republic, France, Greece, Hungary, Ireland, Israel, Portugal, Spain and Turkey, UK, and US. 55 of these 72 sites have actively screened at least 1 patient and 31 have randomized at least 1 patient.
Congratulations go to Dr. Lamer’s site (Institut Mutualiste Montsouris, Paris, France), Dr. Vlachogiani’s site (Agios Dimitrios General Hospital of Thessaloniki, Greece) and Dr. Zervos’ site (Henry Ford Health System, Detroit, US) who have recently successfully randomized their first patient. The patient at Dr Zervos’ site was also the first patient that was randomized in the US.
In addition, an EVADE poster was presented at the ECCMID 2018 in Madrid, showing the results from the interim PK analysis on 20 subjects. Based on this analysis, the Data Monitoring Committee recommended to not change the MEDI3902 dose and to continue the EVADE trial with the dosing that is described in the current protocol.
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.