Overview

Calfactant for Direct Acute Respiratory Distress Syndrome

Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pneuma Pharmaceuticals Incorporated
Treatments:
Calfactant
Criteria
Inclusion Criteria:

1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning,
smoke inhalation or industrial gas

2. Less than 48 hours of mechanical ventilation

3. Informed consent

Exclusion Criteria:

1. Pre-existing lung disease

2. coma

3. limited therapeutic goals (do not resuscitate, etc.)

4. failure of another vital organ