TerminatedPhase 3

Calfactant for Direct Acute Respiratory Distress Syndrome

Stopped: Expected mortality rates in placebo and treatment groups lower than predicted

United States332 participantsStarted 2008-05

Plain-language 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.

Who can participate

Age range12 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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 criteria

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

What they're measuring

Mortality Rate

Timeframe: 90 days

Trial details

NCT IDNCT00682500

SponsorPneuma Pharmaceuticals Incorporated

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Adult trials