Calfactant for Direct Acute Respiratory Distress Syndrome
- Conditions
- Respiratory Distress Syndrome, Adult
- Interventions
- Drug: Room Air (placebo)Drug: Calfactant
- Registration Number
- NCT00682500
- Lead Sponsor
- Pneuma Pharmaceuticals Incorporated
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 332
- Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- Less than 48 hours of mechanical ventilation
- Informed consent
- Pre-existing lung disease
- coma
- limited therapeutic goals (do not resuscitate, etc.)
- failure of another vital organ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Room Air (placebo) - 1 Calfactant Calfactant treatment
- Primary Outcome Measures
Name Time Method Mortality Rate 90 days
- Secondary Outcome Measures
Name Time Method Duration of mechanical ventilation 90 days
Trial Locations
- Locations (32)
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Surrey Memorial Hospital
🇨🇦Vancouver, British Columbia, Canada
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Uthscsa/Stvah
🇺🇸San Antonio, Texas, United States
Northwestern University-Chicago
🇺🇸Chicago, Illinois, United States
Clarian Health, Inc/Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Columbia Medical Center--Pediatrics
🇺🇸New York, New York, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Auckland City Hospital
🇳🇿Auckland City, Auckland, New Zealand
Rabin Medical Center
🇮🇱Jerusalem, Israel
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Haemek Medical Center
🇮🇱Jerusalem, Israel
University of Florida
🇺🇸Gainesville, Florida, United States
Peoria Pulmonary Associates/OSF St. Francis Hospital
🇺🇸Peoria, Illinois, United States
Penn State University
🇺🇸Hershey, Pennsylvania, United States
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
University of Virginia Health Science Center
🇺🇸Charlottesville, Virginia, United States
West Suburban Hospital Medical Center
🇺🇸Oak Park, Illinois, United States
Baylor College of Medicine/Texas Children's Hospital
🇺🇸Houston, Texas, United States
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Creighton University
🇺🇸Omaha, Nebraska, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Florida Hospital and Florida Children's Hospital
🇺🇸Orlando, Florida, United States
Omaha Children's Hospital
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States