Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

July 23, 2012 updated by: Pneuma Pharmaceuticals Incorporated

Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children

This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated <48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Royal Columbian Hospital
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada
        • British Columbia Children's Hospital
      • Vancouver, British Columbia, Canada
        • Surrey Memorial Hospital
    • Ontario
      • Kingston, Ontario, Canada
        • Kingston General Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa Hospital
  • Israel
      • Jerusalem, Israel
        • Haemek Medical Center
      • Jerusalem, Israel
        • Rabin Medical Center
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • New Zealand
      • Auckland, New Zealand
        • Starship Children's Hospital
    • Auckland
      • Auckland City, Auckland, New Zealand
        • Auckland City Hospital
  • United States
    • Florida
      • Gainesville, Florida, United States
        • University of Florida
      • Orlando, Florida, United States
        • Florida Hospital and Florida Children's Hospital
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University-Chicago
      • Oak Park, Illinois, United States
        • West Suburban Hospital Medical Center
      • Peoria, Illinois, United States
        • Peoria Pulmonary Associates/OSF St. Francis Hospital
    • Indiana
      • Indianapolis, Indiana, United States
        • Clarian Health, Inc/Methodist Hospital
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University
      • Omaha, Nebraska, United States, 68198
        • Omaha Children's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States
        • Columbia Medical Center--Pediatrics
    • Oregon
      • Portland, Oregon, United States
        • The Oregon Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Penn State University
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine/Texas Children's Hospital
      • San Antonio, Texas, United States
        • Uthscsa/Stvah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health Science Center
      • Fairfax, Virginia, United States
        • Inova Fairfax Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
  2. Less than 48 hours of mechanical ventilation
  3. Informed consent

Exclusion Criteria:

  1. Pre-existing lung disease
  2. coma
  3. limited therapeutic goals (do not resuscitate, etc.)
  4. failure of another vital organ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Room Air (placebo)
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
Other Names:
  • placebo
Experimental: 1
Calfactant treatment
Drug: Calfactant
Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
Other Names:
  • PneumoSurf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality Rate
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of mechanical ventilation
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pneuma Pharmaceuticals Incorporated

Investigators

  • Study Chair: Douglas Willson, MD, Univeristy of Virginia Health Sciences Center
  • Study Chair: Jonathon Truwit, MD, University of Virginia Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pneuma AR-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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