Calfactant for Direct Acute Respiratory Distress Syndrome
NCT ID: NCT00682500
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
332 participants
INTERVENTIONAL
2008-05-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Calfactant treatment
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.
2
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
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Less than 48 hours of mechanical ventilation
3. Informed consent
Exclusion Criteria
2. coma
3. limited therapeutic goals (do not resuscitate, etc.)
4. failure of another vital organ
12 Years
85 Years
ALL
No
Sponsors
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Pneuma Pharmaceuticals Incorporated
OTHER
Responsible Party
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Principal Investigators
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Douglas Willson, MD
Role: STUDY_CHAIR
Univeristy of Virginia Health Sciences Center
Jonathon Truwit, MD
Role: STUDY_CHAIR
University of Virginia Health Sciences Center
Locations
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University of Florida
Gainesville, Florida, United States
Florida Hospital and Florida Children's Hospital
Orlando, Florida, United States
Northwestern University-Chicago
Chicago, Illinois, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, United States
Peoria Pulmonary Associates/OSF St. Francis Hospital
Peoria, Illinois, United States
Clarian Health, Inc/Methodist Hospital
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Creighton University
Omaha, Nebraska, United States
Omaha Children's Hospital
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia Medical Center--Pediatrics
New York, New York, United States
The Oregon Clinic
Portland, Oregon, United States
Penn State University
Hershey, Pennsylvania, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Uthscsa/Stvah
San Antonio, Texas, United States
University of Virginia Health Science Center
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Columbian Hospital
New Westminster, British Columbia, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Surrey Memorial Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Haemek Medical Center
Jerusalem, , Israel
Rabin Medical Center
Jerusalem, , Israel
Auckland City Hospital
Auckland, Auckland, New Zealand
Starship Children's Hospital
Auckland, New Zealand, New Zealand
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EE. The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Chest. 2015 Aug;148(2):356-364. doi: 10.1378/chest.14-1139.
Other Identifiers
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Pneuma AR-06
Identifier Type: -
Identifier Source: org_study_id