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Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : December 2010
Study Completion Date : February 2011


Arms and Interventions

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


Outcome Measures

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

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

Eligibility Criteria

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
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00682500


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pneuma Pharmaceuticals Incorporated
ClinicalTrials.gov 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:
Pneumonia
Aspiration
Drowning
inhalation

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