Study Stopped
Expected mortality rates in placebo and treatment groups lower than predicted
Calfactant for Direct Acute Respiratory Distress Syndrome
CARDS
Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
1 other identifier
interventional
332
6 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2008
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJuly 24, 2012
July 1, 2012
2.6 years
May 20, 2008
July 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality Rate
90 days
Secondary Outcomes (1)
Duration of mechanical ventilation
90 days
Study Arms (2)
1
EXPERIMENTALCalfactant treatment
2
PLACEBO COMPARATORInterventions
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.
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
Eligibility Criteria
You may qualify if:
- Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- Less than 48 hours of mechanical ventilation
- Informed consent
You may not qualify if:
- Pre-existing lung disease
- coma
- limited therapeutic goals (do not resuscitate, etc.)
- failure of another vital organ
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 68131, United States
Omaha Children's Hospital
Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia Medical Center--Pediatrics
New York, New York, United States
The Oregon Clinic
Portland, Oregon, United States
Penn State University
Hershey, Pennsylvania, United States
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States
Uthscsa/Stvah
San Antonio, Texas, United States
University of Virginia Health Science Center
Charlottesville, Virginia, 22908, United States
INOVA Fairfax Hospital
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Columbian Hospital
New Westminster, British Columbia, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Surrey Memorial Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Haemek Medical Center
Jerusalem, Israel
Rabin Medical Center
Jerusalem, Israel
Auckland City Hospital
Auckland, Auckland, New Zealand
Starship Children's Hospital
Auckland, New Zealand, New Zealand
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 25855884DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Douglas Willson, MD
Univeristy of Virginia Health Sciences Center
- STUDY CHAIR
Jonathon Truwit, MD
University of Virginia Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 22, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
July 24, 2012
Record last verified: 2012-07