Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation

Primary Objective:

- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation

Secondary Objectives:

• To determine the safety and tolerability of SAR279356
• To evaluate the pharmacodynamics (PD) and immunogenicity of SAR279356
• Exploratory efficacy of SAR279356 on prevention of bacterial infections

Total study duration (from screening to last follow-up visit) is 91 days break down as follows:

• Screening: 1 day prior to dosing;
• Treatment period: one IV injection on Day 1;
• Follow-up period: 90 days

Inclusion criteria :

• ICU patients on mechanical ventilation at the time of randomization
• Patients or legally authorized representative (LAR) giving written informed consent.

Exclusion criteria:

• Patients <18 years of age;
• Documented Pseudomonas infection or colonization in the last 30 days;
• Immunocompromised patients
• Hypersensitivity to the study drug and/or to prior therapy with monoclonal antibodies;
• Patient who has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 half-lives, whichever is longer;
• Patient or LAR who withdraws consent during the screening (starting from signed informed consent form);
• Acute liver injury related criteria at the time of study entry:
• Pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.