Calfactant for Direct Acute Respiratory Distress Syndrome

Phase 3 Terminated 332 enrolled Pneuma Pharmaceuticals Incorporated

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-05
Primary completion: 2010-12
Completion: 2011-02

Outcome

Missed primary endpoint

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

paper Calfactant administration was not associated with improved survival, lengths of stay, or oxygenation. PMID 25855884 ↗

Publications

Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EE. The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Chest. 2015 Aug;148(2):356-364. doi: 10.1378/chest.14-1139.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calfactant	Protein / enzyme biologic	60 mg/ml	Other