Expired Study
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Gainesville, Florida


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.


Study summary:

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.


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


Study is Available At:


Original ID:

Pneuma AR-06


NCT ID:

NCT00682500


Secondary ID:


Study Acronym:

CARDS


Brief Title:

Calfactant for Direct Acute Respiratory Distress Syndrome


Official Title:

Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pneuma Pharmaceuticals Incorporated


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Expected mortality rates in placebo and trea


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

332


Enrollment Type:

Actual


Overall Contact Information

Official Name:Douglas Willson, MD
Study Chair
Univeristy of Virginia Health Sciences Center

Study Dates

Start Date:May 2008
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 23, 2012
First Received Date:May 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mortality Rate
Time Frame:90 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of mechanical ventilation
Time Frame:90 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Calfactant
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.
Arm Name:1
Other Name:PneumoSurf
Intervention Type:Drug
Name:Room Air (placebo)
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
Arm Name:2
Other Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Calfactant treatment
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Pneuma Pharmaceuticals Incorporated

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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