Calfactant for Direct Acute Respiratory Distress Syndrome
Information source: Pneuma Pharmaceuticals Incorporated
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Distress Syndrome, Adult
Intervention: Calfactant (Drug); Room Air (placebo) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pneuma Pharmaceuticals Incorporated Official(s) and/or principal investigator(s):
Douglas Willson, MD, Study Chair, Affiliation: Univeristy of Virginia Health Sciences Center
Jonathon Truwit, MD, Study Chair, Affiliation: University of Virginia Health Sciences Center
Overall contact:
Christine Traul, MD, Phone: 434-982-3973, Email: CT6Q@hscmail.mcc.virginia.edu
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.
Clinical Details
Official title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Mortality Rate
Secondary outcome: Duration of mechanical ventilation
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
Minimum age: 1 Month.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Christine Traul, MD, Phone: 434-982-3973, Email: CT6Q@hscmail.mcc.virginia.edu
Florida Hospital and Florida Children's Hospital, Orlando, Florida, United States; Recruiting
Aaron Godshall, Email: ajg@floridapediatrics.com
Corina Mattix, Email: cmattix@seclinical.com
Aaron Godshall, MD, Principal Investigator
Michael Rodricks, MD, Principal Investigator
Jackson Memorial Hospital/University of Miami, Miami, Florida, United States; Recruiting
Fernando Cubillos, MD, Phone: 305-585-6664, Email: fcubillos@med.miami.edu
Gwenn McLaughlin, MD, Principal Investigator
Roland Schein, MD, Principal Investigator
Northwestern University-Chicago, Chicago, Illinois, United States; Recruiting
Helen Donnelly, RN, Phone: 312-695-1881, Email: h-donnelly@northwestern.edu
Sarice Bassin, MD, Principal Investigator
Richard Wunderink, MD, Principal Investigator
West Suburban Hospital Medical Center, Oak Park, Illinois, United States; Recruiting
Kelly Maple, RN, Phone: 708-763-6757, Email: kelly.maple@reshealthcare.org
Tony Marinelli, MD, Principal Investigator
Clarian Health, Inc/Methodist Hospital, Indianapolis, Indiana, United States; Not yet recruiting
Christopher Naum, Email: cnaum@clarian.org
Annie Thorp, Email: athorp2@clarian.org
Christopher Naum, MD, Principal Investigator
Riley Children's Hospital/Indiana University, Indianapolis, Indiana, United States; Recruiting
Lisa Bendy, RRT, Phone: 317-274-3201, Email: lbendy@iupui.edu
Kris Bysani, MD, Phone: 317-274-7208, Email: gbysani@iupui.edu
Kris Bysani, MD, Principal Investigator
Omaha Children's Hospital, Omaha, Nebraska 68198, United States; Recruiting
Machelle Zink, RN, Phone: 402-559-5698, Email: mazink@unmc.edu
Ed Truemper, MD, Email: etruemper@chsomaha.org
Ed Truemper, MD, Principal Investigator
Creighton University, Omaha, Nebraska 68131, United States; Recruiting
Amy Keyes, RRT, Email: Amykeyes@creighton.edu
Lee Morrow, MD, Email: leemorrow@creighton.edu
Lee Morrow, MD, Principal Investigator
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States; Recruiting
Dean Jarvis, BSN, MBA, Phone: 603-653-3756, Email: j.dean.jarvis@hitchcock.org
Harold Manning, MD, Principal Investigator
Cincinnati Children's Hospital, Cincinnati, Ohio, United States; Active, not recruiting
Nationwide Children's Hospital, Columbus, Ohio, United States; Recruiting
Patsy Guittar, RN, BSN, Phone: 614-722-2650, Email: patsy.guittar@nationwidechildrens.org
Margaret Chase, MD, Principal Investigator
University of Cincinnati Medical Center, Cincinnati, Ohio, United States; Active, not recruiting
Ohio State University Medical Center, Columbus, Ohio, United States; Active, not recruiting
The Oregon Clinic, Portland, Oregon, United States; Recruiting
Kim LaMorticella, BS, Phone: 503-963-3031, Email: klamorticella@orclinic.com
Rhett Cummings, MD, Principal Investigator
Penn State University, Hershey, Pennsylvania, United States; Active, not recruiting
University of Virginia Health Science Center, Charlottesville, Virginia 22908, United States; Recruiting
Douglas Willson, MD, Phone: 434-982-1707, Email: dfw4m@hscmail.mcc.virginia.edu
Christine Traul, MD, Phone: 434-982-3973, Email: CT6Q@hscmail.mcc.virginia.edu
Douglas Willson, MD, Principal Investigator
Ajeet Vinayak, MD, Principal Investigator
INOVA Fairfax Hospital, Fairfax, Virginia, United States; Recruiting
Kathi Huddleston, RRT, PhD, Phone: 703-776-2010
Keith Dockery, MD, Principal Investigator
James Lamberti, MD, Principal Investigator
Medical College of Wisconsin, Milwaukee, Wisconsin, United States; Recruiting
Melita Baldwin, Phone: 414-955-2377, Email: mebaldwin@mcw.edu
Michael Quasney, MD, Principal Investigator
Rahul Nanchal, MD, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: September 2010
Last updated: September 4, 2008
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