Calfactant for Direct Acute Respiratory Distress Syndrome

Respiratory Distress Syndrome, Adult Clinical Trial

— CARDS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00682500
• Other study ID #: Pneuma AR-06
• Status: Terminated
• Phase: Phase 3
• First received: May 20, 2008
• Last updated: July 23, 2012
• Start date: May 2008
• Est. completion date: February 2011

Study information

• Verified date: July 2012
• Source: Pneuma Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 332
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Canada	Surrey Memorial Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Israel	Haemek Medical Center	Jerusalem
Israel	Rabin Medical Center	Jerusalem
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
New Zealand	Starship Children's Hospital	Auckland
New Zealand	Auckland City Hospital	Auckland City	Auckland
United States	University of Virginia Health Science Center	Charlottesville	Virginia
United States	Northwestern University-Chicago	Chicago	Illinois
United States	INOVA Fairfax Hospital	Fairfax	Virginia
United States	University of Florida	Gainesville	Florida
United States	Penn State University	Hershey	Pennsylvania
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas
United States	Clarian Health, Inc/Methodist Hospital	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Columbia Medical Center--Pediatrics	New York	New York
United States	West Suburban Hospital Medical Center	Oak Park	Illinois
United States	Creighton University	Omaha	Nebraska
United States	Omaha Children's Hospital	Omaha	Nebraska
United States	Florida Hospital and Florida Children's Hospital	Orlando	Florida
United States	Peoria Pulmonary Associates/OSF St. Francis Hospital	Peoria	Illinois
United States	The Oregon Clinic	Portland	Oregon
United States	Uthscsa/Stvah	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pneuma Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Korea, Republic of,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate		90 days	No
Secondary	Duration of mechanical ventilation		90 days	No