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

NCT01389700 | Terminated Phase 2

• 2 other identifiers: PKD11791U1111-1118-6717
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 6

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

Conditions

Infection Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics parameters of SAR279356 : Ceoi, AUClast and CL

  90 days

Secondary Outcomes (4)

• 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

Study Arms (3)

SAR279356 dose 1

EXPERIMENTAL

SAR279356 dose 1, single administration

Drug: SAR279356

SAR279356 dose 2

EXPERIMENTAL

SAR279356 dose 2, single administration

Drug: SAR279356

Placebo

PLACEBO COMPARATOR

Matching placebo, single administration

Drug: placebo

Interventions

SAR279356 DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

SAR279356 dose 1; SAR279356 dose 2

placebo DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients on mechanical ventilation at the time of randomization
• Patients or legally authorized representative (LAR) giving written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (6)

Investigational Site Number 840010

Los Angeles, California, 90024, United States

Location

Investigational Site Number 840020

Stanford, California, 94305, United States

Location

Investigational Site Number 840006

Jacksonville, Florida, 32209, United States

Location

Investigational Site Number 840001

Pikeville, Kentucky, 41501, United States

Location

Investigational Site Number 840009

Butte, Montana, 59701, United States

Location

Investigational Site Number 840003

Camden, New Jersey, 08103, United States

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 12, 2014

Record last verified: 2014-11

Locations

US (6)