Status:
TERMINATED
Calfactant for Direct Acute Respiratory Distress Syndrome
Lead Sponsor:
Pneuma Pharmaceuticals Incorporated
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
12-85 years
Phase:
PHASE3
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 ...
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 drownin...
Eligibility Criteria
Inclusion
- Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- Less than 48 hours of mechanical ventilation
- Informed consent
Exclusion
- Pre-existing lung disease
- coma
- limited therapeutic goals (do not resuscitate, etc.)
- failure of another vital organ
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT00682500
Start Date
May 1 2008
End Date
February 1 2011
Last Update
July 24 2012
Active Locations (32)
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1
University of Florida
Gainesville, Florida, United States
2
Florida Hospital and Florida Children's Hospital
Orlando, Florida, United States
3
Northwestern University-Chicago
Chicago, Illinois, United States
4
West Suburban Hospital Medical Center
Oak Park, Illinois, United States