NCT00682500

Calfactant for Direct Acute Respiratory Distress Syndrome

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Pneuma Pharmaceuticals Incorporated · Academic / Other
• Sex: All
• Age: 12 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
DRUG	Calfactant	Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
DRUG	Room Air (placebo)	Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2008-05-22
• Last updated: 2012-07-24

Locations

32 sites across 6 countries: United States, Australia, Canada, Israel, New Zealand, South Korea