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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Infection Prophylaxis

In brief

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

Key facts

Study ID

NCT01389700

Run by

Sanofi

People needed

7

Starts

2011-10-01

Expected to finish

2012-12-01

Last updated by the study team

2014-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840010 — Los Angeles, California, United States
• Investigational Site Number 840020 — Stanford, California, United States
• Investigational Site Number 840006 — Jacksonville, Florida, United States
• Investigational Site Number 840001 — Pikeville, Kentucky, United States
• Investigational Site Number 840009 — Butte, Montana, United States
• Investigational Site Number 840003 — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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