To date 355 subjects have been enrolled in COMBACTE-MAGNET’s EVADE study, of which 287 have been screen failed and 65 randomized.
Currently, there are 60 active sites in Austria, Belgium, Croatia, Czech Republic, France, Greece, Hungary, Israel, Portugal, Spain and Turkey. 45 of these 60 sites have actively screened at least 1 patient and 25 have randomized at least 1 patient. Congratulations go to Dr Koksal’s site (Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey) and Dr Sramek’s site (Fakultni nemocnice u sv. Anny v Brne, Brno, Czech Republic), who have recently successfully randomized their first patient.
A special thanks goes out to the sites of Dr. Bourgeois (AZ Sint-Jan, Brugge, Belgium) and Dr. François (CHU Limoges, Limoges, France), who have both recently randomized their 10th patient and are the top enrollers for EVADE.
The clinical team is continuously pursuing further site “boosting” activities which to this point have not only included individualized training sessions for sites at Limoges, but also direct interactions between the site staff and medical monitor (e.g. rotating calls with the PI and personal site visits). To-date, the medical monitor, Dr. Hasan Jafri, has personally visited sites in Greece, Portugal, Spain, and Belgium, while Dr. Bruno François has visited some sites in Czech Republic in October. In December Dr. Jafri plans to visit some of the French sites.
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.