635. Efficacy, Pharmacokinetics (PK), and Safety Profile of MEDI3902, an Anti-Pseudomonas aeruginosa Bispecific Human Monoclonal Antibody in Mechanically Ventilated Intensive Care Unit Patients; Results of the Phase 2 EVADE Study Conducted by the Public-Private COMBACTE-MAGNET Consortium in the Innovative Medicines Initiative (IMI) Program

ABSTRACT: Abstract

Background

Pseudomonas aeruginosa (PA) pneumonia is associated with morbidity and mortality in mechanically ventilated, intensive care unit (MV ICU) patients despite best clinical care. We assessed efficacy, PK, and safety of MEDI3902 in MV ICU subjects in the placebo-controlled, randomized Phase 2 EVADE study (NCT02696902; EudraCT 2015-001706-34).

Methods

Subjects with PCR-confirmed PA colonization of the lower respiratory tract were randomized to either a single IV infusion of 1,500 mg MEDI3902 (n = 85) or placebo (n = 83). Primary Efficacy endpoint was Endpoint Adjudication Committee-determined relative risk reduction (RRR) of PA pneumonia incidence in MEDI3902 vs. placebo recipients within 21 days post dose (2-sided α = 0.2). Serum MEDI3902 PK levels were mea

SUBMITTER: Chastre J 

PROVIDER: S-EPMC7776862 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature