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

Summary

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

Timeline

Start

2011-10

Primary completion

2012-12

Completion

2012-12

Outcome

Outcome not reported

Stopped (Enrollment): “Difficulty in patient recruitment in the participating sites”

Drugs

Indications

No indication recorded.