MedTrace Logo

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

NCT01389700 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-12-12

No results posted yet for this study

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

Conditions

  • Infection Prophylaxis

Interventions

DRUG

SAR279356

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

DRUG

placebo

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389700 on ClinicalTrials.gov