Clinical trial NCT00682500: Calfactant for Direct Acute Respiratory Distress Syndrome
Official title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Pneumonia
Aspiration
Drowning
inhalation
Lead sponsor: Pneuma Pharmaceuticals Incorporated
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 332
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality Rate
timeFrame: 90 days
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 90 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital and Florida Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University-Chicago
state: Illinois
city: Oak Park
country: United States
facility: West Suburban Hospital Medical Center
state: Illinois
city: Peoria
country: United States
facility: Peoria Pulmonary Associates/OSF St. Francis Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Clarian Health, Inc/Methodist Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Omaha
country: United States
facility: Omaha Children's Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia Medical Center--Pediatrics
state: New York
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Uthscsa/Stvah
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health Science Center
state: Virginia
city: Fairfax
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Jerusalem
country: Israel
facility: Haemek Medical Center
city: Jerusalem
country: Israel
facility: Rabin Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Auckland City
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
Study officials:
affiliation: Univeristy of Virginia Health Sciences Center
name: Douglas Willson, MD
role: STUDY_CHAIR
affiliation: University of Virginia Health Sciences Center
name: Jonathon Truwit, MD
role: STUDY_CHAIR
References:
citation: 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.