Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
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ClinicalTrials.gov Identifier: NCT01389700 |
Recruitment Status :
Terminated
(Difficulty in patient recruitment in the participating sites)
First Posted : July 8, 2011
Last Update Posted : December 12, 2014
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection Prophylaxis | Drug: SAR279356 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-blind, Placebo-controlled Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of SAR279356 in Patients Hospitalized in Intensive Care Unit and on Mechanical Ventilation |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: SAR279356 dose 1
SAR279356 dose 1, single administration
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Drug: SAR279356
Pharmaceutical form: solution for infusion Route of administration: intravenous infusion |
Experimental: SAR279356 dose 2
SAR279356 dose 2, single administration
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Drug: SAR279356
Pharmaceutical form: solution for infusion Route of administration: intravenous infusion |
Placebo Comparator: Placebo
Matching placebo, single administration
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Drug: placebo
Pharmaceutical form: solution for infusion Route of administration: intravenous infusion |
- Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [ Time Frame: 90 days ]
- Opsonophagocytic assay (OPA) [ Time Frame: 90 days ]
- Opsonophagocytic killing assay (OPK) [ Time Frame: 90 days ]
- Dosage of human anti-human antibodies (HAHA) [ Time Frame: 90 days ]
- Occurrence of infections [ Time Frame: Up to 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- ICU patients on mechanical ventilation at the time of randomization
- Patients or legally authorized representative (LAR) giving written informed consent.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389700
United States, California | |
Investigational Site Number 840010 | |
Los Angeles, California, United States, 90024 | |
Investigational Site Number 840020 | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Investigational Site Number 840006 | |
Jacksonville, Florida, United States, 32209 | |
United States, Kentucky | |
Investigational Site Number 840001 | |
Pikeville, Kentucky, United States, 41501 | |
United States, Montana | |
Investigational Site Number 840009 | |
Butte, Montana, United States, 59701 | |
United States, New Jersey | |
Investigational Site Number 840003 | |
Camden, New Jersey, United States, 08103 |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01389700 |
Other Study ID Numbers: |
PKD11791 U1111-1118-6717 ( Other Identifier: UTN ) |
First Posted: | July 8, 2011 Key Record Dates |
Last Update Posted: | December 12, 2014 |
Last Verified: | November 2014 |