Clinical trial NCT01389700: Pharmacokinetics, Pharmacodynamics and Safety Evaluation of SAR279356 in Intensive Care Unit Mechanically Ventilated Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infection Prophylaxis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
measure: Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL
timeFrame: 90 days
Secondary outcomes:
measure: Opsonophagocytic assay (OPA)
timeFrame: 90 days
measure: Opsonophagocytic killing assay (OPK)
timeFrame: 90 days
measure: Dosage of human anti-human antibodies (HAHA)
timeFrame: 90 days
measure: Occurrence of infections
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site Number 840010
state: California
city: Stanford
country: United States
facility: Investigational Site Number 840020
state: California
city: Jacksonville
country: United States
facility: Investigational Site Number 840006
state: Florida
city: Pikeville
country: United States
facility: Investigational Site Number 840001
state: Kentucky
city: Butte
country: United States
facility: Investigational Site Number 840009
state: Montana
city: Camden
country: United States
facility: Investigational Site Number 840003
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: