Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial

Jean Chastre, Bruno François, Marc Bourgeois, Apostolos Komnos, Ricard Ferrer, Galia Rahav, Nicolas De Schryver, Alain Lepape, Iftihar Koksal, Charles-Edouard Luyt, Miguel Sánchez-García, Antoni Torres, Philippe Eggimann, Despoina Koulenti, Thomas L. Holland, Omar Ali, Kathryn Shoemaker, Pin Ren, Julien Sauser, Alexey Ruzin, David E. Tabor, Ahmad Akhgar, Yuling Wu, Yu Jiang, Antonio DiGiandomenico … & Hasan S. Jafri
Abstract Background Ventilator-associated pneumonia caused by Pseudomonas aeruginosa (PA) in hospitalised patients is associated with high mortality. The effectiveness of the bivalent, bispecific mAb MEDI3902 (gremubamab) in preventing PA nosocomial pneumonia was assessed in PA-colonised mechanically ventilated subjects. Methods EVADE (NCT02696902) was a phase 2, randomised, parallel-group, double-blind, placebo-controlled study in Europe, Turkey, Israel, and the USA. Subjects ≥ 18 years old, mechanically ventilated, tracheally colonised with PA, and without new-onset pneumonia, were randomised (1:1:1)...
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