Respiratory Distress Syndrome, AdultPhase 3CARDSNCT00682500
Calfactant for Direct Acute Respiratory Distress Syndrome
A Phase 3 study testing Calfactant in people with Respiratory Distress Syndrome, Adult, run by Pneuma Pharmaceuticals Incorporated at 32 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Calfactant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 32 sitesin 6 countries
- Study dates
- May 2008to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- Less than 48 hours of mechanical ventilation
- Informed consent
Who cannot join
- Pre-existing lung disease
- coma
- limited therapeutic goals (do not resuscitate, etc.)
- failure of another vital organ
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States18 sites
University of Virginia Health Science Center
Charlottesville, Virginia, 22908
Northwestern University-Chicago
Chicago, Illinois
INOVA Fairfax Hospital
Fairfax, Virginia
University of Florida
Gainesville, Florida
Penn State University
Hershey, Pennsylvania
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas
Clarian Health, Inc/Methodist Hospital
Indianapolis, Indiana
University of Iowa
Iowa City, Iowa
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
Medical College of Wisconsin
Milwaukee, Wisconsin
Columbia Medical Center--Pediatrics
New York, New York
West Suburban Hospital Medical Center
Oak Park, Illinois
Creighton University
Omaha, Nebraska, 68131
Omaha Children's Hospital
Omaha, Nebraska, 68198
Florida Hospital and Florida Children's Hospital
Orlando, Florida
Peoria Pulmonary Associates/OSF St. Francis Hospital
Peoria, Illinois
The Oregon Clinic
Portland, Oregon
Uthscsa/Stvah
San Antonio, Texas
Canada7 sites
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario
Royal Columbian Hospital
New Westminster, British Columbia
Ottawa Hospital
Ottawa, Ontario
British Columbia Children's Hospital
Vancouver, British Columbia
Surrey Memorial Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
New Zealand2 sites
Auckland City Hospital
Auckland, Auckland
Starship Children's Hospital
Auckland, New Zealand
About this study
Official title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Calfactant, Room Air (placebo)
- Keywords
- Pneumonia, Aspiration, Drowning, inhalation
- Medical subject headings
- Respiratory Distress Syndrome, Pneumonia, Drowning, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalfactantDrug
Also called PneumoSurf
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)Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Calfactant treatment Receives: Drug: Calfactant |
| 2 | Placebo comparator | Not described Receives: Drug: Room Air (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Measured: 90 days
Secondary outcomes (1)
Duration of mechanical ventilation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionFeb 2011
Why it stopped: Expected mortality rates in placebo and treatment groups lower than predicted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneuma Pharmaceuticals Incorporated
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Willson, MD, Study chair, Univeristy of Virginia Health Sciences CenterJonathon Truwit, MD, Study chair, University of Virginia Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682500
- Sponsor's protocol ID
- Pneuma AR-06
- Acronym
- CARDS
- Status last verified
- Jul 2012
- First submitted
- 20 May 2008
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25855884
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
- ClinicalTrials.gov ID
- NCT00682500
- Acronym / sponsor ID
- CARDS / Pneuma AR-06
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Pneumonia, Aspiration, Drowning, inhalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expected mortality rates in placebo and treatment groups lower than predicted
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Pneuma Pharmaceuticals IncorporatedUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CalfactantCalfactant treatment |
| 2 | Placebo comparator | Drug: Room Air (placebo) |
Who may qualify
- Ages
- 12 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
- Less than 48 hours of mechanical ventilation
- Informed consent
Key exclusion criteria (4 listed)
- Pre-existing lung disease
- coma
- limited therapeutic goals (do not resuscitate, etc.)
- failure of another vital organ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalfactantAlso: PneumoSurfIntratracheal 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. | Drug | 1 |
| Room Air (placebo)Also: placeboAdministration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met | Drug | 2 |
Primary outcome
Mortality Rate
Time frame: 90 days
1 secondary outcome
Duration of mechanical ventilation
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Expected mortality rates in placebo and treatment groups lower than predicted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Derived from this study: PubMed 25855884Willson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Willson, MD study chair
Univeristy of Virginia Health Sciences Center
Jonathon Truwit, MD study chair
University of Virginia Health Sciences Center
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calfactant in people with Respiratory Distress Syndrome, Adult, run by Pneuma Pharmaceuticals Incorporated at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada, Israel, New Zealand, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Expected mortality rates in placebo and treatment groups lower than predicted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.