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Calfactant for Direct Acute Respiratory Distress Syndrome (CARDS)

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Calfactant
Room Air (placebo)
Sponsored by
Pneuma Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Pneumonia, Aspiration, Drowning, inhalation

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • Florida Hospital and Florida Children's Hospital
  • Northwestern University-Chicago
  • West Suburban Hospital Medical Center
  • Peoria Pulmonary Associates/OSF St. Francis Hospital
  • Clarian Health, Inc/Methodist Hospital
  • University of Iowa
  • Creighton University
  • Omaha Children's Hospital
  • Dartmouth-Hitchcock Medical Center
  • Columbia Medical Center--Pediatrics
  • The Oregon Clinic
  • Penn State University
  • Baylor College of Medicine/Texas Children's Hospital
  • Uthscsa/Stvah
  • University of Virginia Health Science Center
  • INOVA Fairfax Hospital
  • Medical College of Wisconsin
  • Royal Adelaide Hospital
  • Royal Columbian Hospital
  • British Columbia Children's Hospital
  • Surrey Memorial Hospital
  • Vancouver General Hospital
  • Kingston General Hospital
  • London Health Sciences Centre
  • Ottawa Hospital
  • Haemek Medical Center
  • Rabin Medical Center
  • Asan Medical Center
  • Samsung Medical Center
  • Auckland City Hospital
  • Starship Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Calfactant treatment

Outcomes

Primary Outcome Measures

Mortality Rate

Secondary Outcome Measures

Duration of mechanical ventilation

Full Information

First Posted
May 20, 2008
Last Updated
July 23, 2012
Sponsor
Pneuma Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00682500
Brief Title
Calfactant for Direct Acute Respiratory Distress Syndrome
Acronym
CARDS
Official Title
Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Expected mortality rates in placebo and treatment groups lower than predicted
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pneuma Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
Pneumonia, Aspiration, Drowning, inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Calfactant treatment
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calfactant
Other Intervention Name(s)
PneumoSurf
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Room Air (placebo)
Other Intervention Name(s)
placebo
Intervention Description
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
Primary Outcome Measure Information:
Title
Mortality Rate
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas Less than 48 hours of mechanical ventilation Informed consent Exclusion Criteria: Pre-existing lung disease coma limited therapeutic goals (do not resuscitate, etc.) failure of another vital organ
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Willson, MD
Organizational Affiliation
Univeristy of Virginia Health Sciences Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathon Truwit, MD
Organizational Affiliation
University of Virginia Health Sciences Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Florida Hospital and Florida Children's Hospital
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Northwestern University-Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
West Suburban Hospital Medical Center
City
Oak Park
State/Province
Illinois
Country
United States
Facility Name
Peoria Pulmonary Associates/OSF St. Francis Hospital
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Clarian Health, Inc/Methodist Hospital
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Omaha Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
Columbia Medical Center--Pediatrics
City
New York
State/Province
New York
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Penn State University
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Uthscsa/Stvah
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Virginia Health Science Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Haemek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Jerusalem
Country
Israel
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Auckland City Hospital
City
Auckland City
State/Province
Auckland
Country
New Zealand
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25855884
Citation
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.
Results Reference
derived

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Calfactant for Direct Acute Respiratory Distress Syndrome

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