Calfactant for Direct Acute Respiratory Distress Syndrome - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 20, 2008

Last Updated Date

February 5, 2009

Start Date ^†

May 2008

Current Primary Outcome Measures ^†

Mortality Rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00682500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^†

Respiratory Distress Syndrome, Adult

Intervention ^†

Drug: Calfactant
Drug: Room Air (placebo)

Study Arms / Comparison Groups

Experimental: Calfactant treatment

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

480

Estimated Completion Date

September 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

1 Month to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Christine Traul, MD	434-982-3973	CT6Q@hscmail.mcc.virginia.edu
Contact: Douglas Willson, MD	434-982-1707	dfw4m@virginia.edu

Location Countries ^†

United States, Canada, Korea, Republic of

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00682500

Responsible Party

Douglas Willson, MD, University of Virginia Health Science Center

Secondary IDs ^††

Study Sponsor ^†

Pneuma Pharmaceuticals Incorporated

Collaborators ^††

Investigators ^†

Study Chair:	Douglas Willson, MD	Univeristy of Virginia Health Sciences Center
Study Chair:	Jonathon Truwit, MD	University of Virginia Health Sciences Center

Information Provided By

Pneuma Pharmaceuticals Incorporated

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.