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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: March 17, 2014
Last verified: March 2014

July 6, 2011
March 17, 2014
October 2011
December 2012   (final data collection date for primary outcome measure)
Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01389700 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infection Prophylaxis
  • Drug: SAR279356

    Pharmaceutical form: solution for infusion

    Route of administration: intravenous infusion

  • Drug: placebo

    Pharmaceutical form: solution for infusion

    Route of administration: intravenous infusion

  • Experimental: SAR279356 dose 1
    SAR279356 dose 1, single administration
    Intervention: Drug: SAR279356
  • Experimental: SAR279356 dose 2
    SAR279356 dose 2, single administration
    Intervention: Drug: SAR279356
  • Placebo Comparator: Placebo
    Matching placebo, single administration
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01389700
PKD11791, U1111-1118-6717
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP