Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

This study has been terminated.
(Expected mortality rates in placebo and treatment groups lower than predicted)
Sponsor:
Information provided by (Responsible Party):
Pneuma Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00682500
First received: May 20, 2008
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Respiratory Distress Syndrome, Adult
Drug: Calfactant
Drug: Room Air (placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children

Resource links provided by NLM:


Further study details as provided by Pneuma Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Mortality Rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of mechanical ventilation [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: May 2008
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pneuma Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00682500     History of Changes
Other Study ID Numbers: Pneuma AR-06
Study First Received: May 20, 2008
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pneuma Pharmaceuticals Incorporated:
Pneumonia
Aspiration
Drowning
inhalation

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

ClinicalTrials.gov processed this record on November 25, 2014