The EVADE team is very pleased to announce that on the 18th of February the database lock for the study was achieved.
The database was locked following data reconciliation and blinded review of all randomized patients by the adjudication committee, which assessed incidence of pneumonia through 21 days post dose. This important milestone also marks the start of the statistical analysis.
Enrollment into the EVADE study had been terminated on the 18th of October 2019. A total of 1023 subjects were screened into the study of which 188 had been randomized.
Following the database lock, the analysis of the data continues and close-out visits are being planned. The study team would like to take the opportunity to thank the sites for their continued efforts throughout the last few years to get to this point of the study. EVADE would have been impossible without the hard work of the investigators and the staff at the study sites.
EVADE – Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically ventilated Subjects – 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.
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.
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 Database Lock: Central Laboratory Data
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COMBACTE-MAGNET‘s EVADE study has reached an important milestone: the study enrollment has been terminated on the 18th of October. A total of 10...