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

• ClinicalTrials.gov Identifier: NCT01389700
• Recruitment Status: Terminated
• First Posted: July 8, 2011
• Last Update Posted: December 12, 2014
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Infection Prophylaxis	Drug: SAR279356; Drug: placebo	Phase 2

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. Opsonophagocytic assay (OPA) [ Time Frame: 90 days ]
2. Opsonophagocytic killing assay (OPK) [ Time Frame: 90 days ]
3. Dosage of human anti-human antibodies (HAHA) [ Time Frame: 90 days ]
4. Occurrence of infections [ Time Frame: Up to 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01389700
• Other Study ID Numbers: PKD11791; U1111-1118-6717 ( Other Identifier: UTN )
• First Posted: July 8, 2011
• Last Update Posted: December 12, 2014
• Last Verified: November 2014