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- To determine the pharmacokinetics (PK) of a single intravenous (IV) dose of SAR279356 administered to intensive care unit (ICU) patients on mechanical ventilation
- 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
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Investigational Site Number 840024
Published on BioPortfolio: 2014-08-27T04:00:28-0400
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