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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.
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.
Age
12 - 85 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 1, 2008
Primary Completion Date
December 1, 2010
Completion Date
February 1, 2011
Last Updated
July 24, 2012
332
ACTUAL participants
Calfactant
DRUG
Room Air (placebo)
DRUG
Lead Sponsor
Pneuma Pharmaceuticals Incorporated
NCT02273687
NCT01743105
NCT05081895
Data Source & Attribution
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