Calfactant for Direct Acute Respiratory Distress Syndrome

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00682500

Run by

Pneuma Pharmaceuticals Incorporated

People needed

332

Starts

2008-05-01

Expected to finish

2011-02-01

Last updated by the study team

2012-07-24

Who can join

Age: 12 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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