2839. Efficacy, Pharmacokinetics (PK), and Safety Profile of Suvratoxumab (MEDI4893), a Staphylococcus aureus Alpha Toxin (AT)-Neutralizing Human Monoclonal Antibody in Mechanically Ventilated Patients in Intensive Care Units; Results of the Phase 2 SAATELLITE Study Conducted by the Public-Private COMBACTE Consortium

ABSTRACT: Abstract

Background

Staphylococcus aureus (SA) pneumonia imposes significant morbidity and mortality in mechanically ventilated, intensive care unit (MV ICU) patients despite best clinical care. We assessed efficacy, PK, AT-neutralizing antibodies (AT NAbs), and safety of suvratoxumab (suvra) in MV ICU subjects in the placebo-controlled, randomized Phase 2 SAATELLITE study (NCT02296320; EudraCT 2014-001097-34).

Methods

Subjects with PCR-confirmed SA colonization of the lower respiratory tract were randomized to either a single intravenous infusion of 5,000 mg suvra (n = 96) or placebo (n = 100) and followed for 190 days post dose. Efficacy endpoints were Endpoint Adjudication Committee-determined relative risk reduction (RRR) of SA pneumonia incidence in suvra vs. placebo

SUBMITTER: Francois B 

PROVIDER: S-EPMC6809370 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature