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

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

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

Study Overview

• Status: Terminated
• Conditions: Infection Prophylaxis
• Intervention / Treatment: Drug: SAR279356; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Investigational Site Number 840010
    • Stanford, California, United States, 94305
      • Investigational Site Number 840020
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Investigational Site Number 840006
  • Kentucky
    • Pikeville, Kentucky, United States, 41501
      • Investigational Site Number 840001
  • Montana
    • Butte, Montana, United States, 59701
      • Investigational Site Number 840009
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Investigational Site Number 840003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Opsonophagocytic assay (OPA)	90 days
Opsonophagocytic killing assay (OPK)	90 days
Dosage of human anti-human antibodies (HAHA)	90 days
Occurrence of infections	Up to 28 days

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (ESTIMATE): July 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: PKD11791; U1111-1118-6717 (OTHER: UTN)