Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00682500
Recruitment Status : Terminated (Expected mortality rates in placebo and treatment groups lower than predicted)
First Posted : May 22, 2008
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Pneuma Pharmaceuticals Incorporated

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Drug: Calfactant Drug: Room Air (placebo) Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Study Start Date : May 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: 1
Calfactant treatment
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.
Other Name: PneumoSurf
Placebo Comparator: 2 Drug: 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
Other Name: placebo

Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00682500

  Show 32 Study Locations
Sponsors and Collaborators
Pneuma Pharmaceuticals Incorporated
Study Chair: Douglas Willson, MD Univeristy of Virginia Health Sciences Center
Study Chair: Jonathon Truwit, MD University of Virginia Health Sciences Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pneuma Pharmaceuticals Incorporated Identifier: NCT00682500     History of Changes
Other Study ID Numbers: Pneuma AR-06
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Pneuma Pharmaceuticals Incorporated:

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Pulmonary Surfactants
Respiratory System Agents