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

This study has been terminated.

(Difficulty in patient recruitment in the participating sites)

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01389700

First received: July 6, 2011

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Infection Prophylaxis	Drug: SAR279356 Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Sanofi:

Primary Outcome Measures:

Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Opsonophagocytic assay (OPA) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Opsonophagocytic killing assay (OPK) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Dosage of human anti-human antibodies (HAHA) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Occurrence of infections [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	October 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SAR279356 dose 1 SAR279356 dose 1, single administration	Drug: SAR279356 Pharmaceutical form: solution for infusion Route of administration: intravenous infusion
Experimental: SAR279356 dose 2 SAR279356 dose 2, single administration	Drug: SAR279356 Pharmaceutical form: solution for infusion Route of administration: intravenous infusion
Placebo Comparator: Placebo Matching placebo, single administration	Drug: placebo Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389700

Locations

United States, Alabama
Investigational Site Number 840024
Birmingham, Alabama, United States, 35294-0006
United States, California
Investigational Site Number 840008
Fresno, California, United States, 93701
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, Illinois
Investigational Site Number 840023
Joliet, Illinois, United States, 60435
United States, Kentucky
Investigational Site Number 840015
Louisville, Kentucky, United States, 40217
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
United States, Pennsylvania
Investigational Site Number 840014
Bethlehem, Pennsylvania, United States, 18015
United States, Tennessee
Investigational Site Number 840021
Memphis, Tennessee, United States, 38104

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01389700 History of Changes
Other Study ID Numbers:	PKD11791, U1111-1118-6717
Study First Received:	July 6, 2011
Last Updated:	January 10, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013

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