Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
NCT ID: NCT01389700
Last Updated: 2014-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2011-10-31
2012-12-31
Brief Summary
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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
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
Detailed Description
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* Screening: 1 day prior to dosing;
* Treatment period: one IV injection on Day 1;
* Follow-up period: 90 days
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SAR279356 dose 1
SAR279356 dose 1, single administration
SAR279356
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
SAR279356 dose 2
SAR279356 dose 2, single administration
SAR279356
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
Placebo
Matching placebo, single administration
placebo
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
Interventions
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SAR279356
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
placebo
Pharmaceutical form: solution for infusion
Route of administration: intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Patients or legally authorized representative (LAR) giving written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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Other Identifiers
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U1111-1118-6717
Identifier Type: OTHER
Identifier Source: secondary_id
PKD11791
Identifier Type: -
Identifier Source: org_study_id