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

2014-08-27 04:00:28 | BioPortfolio

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

Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Infection Prophylaxis

Intervention

SAR279356, placebo

Location

Investigational Site Number 840024
Birmingham
Alabama
United States
35294-0006

Status

Terminated

Source

Sanofi

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:28-0400

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