Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01314066
Phase
PHASE2
Status
Withdrawn

Conditions

  • Acute Respiratory Distress Syndrome
  • Severe Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Patients receiving drug will receive it as a single dose. Treatment will be given as 90-minute IV infusion. The patient will either receive Bevacizumab at 5 mg/kg OR Bevacizumab at 10 mg/kg.
  • Placebo — DRUG
    Patients assigned to placebo-control group will receive a single dose of saline solution as a 90 minute IV infusion

Study Details

This study aims to test the effectiveness of a single intravenous (IV, through the vein) dose of the study drug, bevacizumab (Avastin), in preventing/reducing the development of Acute Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high risk for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung function impairment. The condition the patient has,severe sepsis, is a medical condition associated with an infection characterized as an immune system inflammatory response throughout your whole body that can lead to organ dysfunction, low blood pressure or insufficient blood flow to one or more of your organs.

Key Dates

First listed
Mar 14, 2011
Start date
Jul 31, 2010
Status verified
Apr 2016
Primary completion
Nov 30, 2015
Completion
Feb 29, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Bevacizumab 5 mg/kg
    Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
  • Experimental: Bevacizumab at 10 mg/kg
    Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
  • Placebo Comparator: Placebo
    In addition to receiving the best standard supportive care for both diagnosis and treatment for individuals diagnosed with severe sepsis, they will receive an IV saline solution.

Primary Outcome Measure

Proportion of individuals progressing to meet RDS criteria as defined by the American- European ARDS consensus conference and as used by ARDSnet. [ Time Frame: Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical College-New York Presbyterian HospitalNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Weill Cornell Medical College-New York Presbyterian Hospital· New York, NY

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