Clinical Trial: Calfactant for Direct Acute Respiratory Distress Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children

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 Summary: 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.
Sponsor: Pneuma Pharmaceuticals Incorporated

Current Primary Outcome: Mortality Rate [ Time Frame: 90 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Duration of mechanical ventilation [ Time Frame: 90 days ]

Original Secondary Outcome: Same as current

Information By: Pneuma Pharmaceuticals Incorporated

Dates:
Date Received: May 20, 2008
Date Started: May 2008
Date Completion:
Last Updated: July 23, 2012
Last Verified: July 2012