Calfactant for Direct Acute Respiratory Distress Syndrome

Phase 3

Terminated

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Drug: Room Air (placebo); Drug: Calfactant

• Registration Number: NCT00682500
• Lead Sponsor: Pneuma Pharmaceuticals Incorporated

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 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Room Air (placebo)	-
1	Calfactant	Calfactant treatment

Primary Outcome Measures

Name	Time	Method
Mortality Rate	90 days

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	90 days

Trial Locations

Locations (32)

University of Florida; 🇺🇸 Gainesville, Florida, United States

Florida Hospital and Florida Children's Hospital; 🇺🇸 Orlando, Florida, United States

Northwestern University-Chicago; 🇺🇸 Chicago, Illinois, United States

West Suburban Hospital Medical Center; 🇺🇸 Oak Park, Illinois, United States

Peoria Pulmonary Associates/OSF St. Francis Hospital; 🇺🇸 Peoria, Illinois, United States

Clarian Health, Inc/Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

Omaha Children's Hospital; 🇺🇸 Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

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