Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00682500




Registration number
NCT00682500
Ethics application status
Date submitted
20/05/2008
Date registered
22/05/2008
Date last updated
24/07/2012

Titles & IDs
Public title
Calfactant for Direct Acute Respiratory Distress Syndrome
Scientific title
Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Secondary ID [1] 0 0
Pneuma AR-06
Universal Trial Number (UTN)
Trial acronym
CARDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome, Adult 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Calfactant
Treatment: Drugs - Room Air (placebo)

Experimental: 1 - Calfactant treatment

Placebo Comparator: 2 -


Treatment: Drugs: 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.

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality Rate
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Duration of mechanical ventilation
Timepoint [1] 0 0
90 days

Eligibility
Key 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
Minimum age
12 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Pneuma Pharmaceuticals Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00682500
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas Willson, MD
Address 0 0
Univeristy of Virginia Health Sciences Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00682500