|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pneuma Pharmaceuticals Incorporated |
|---|---|
| Information provided by: | Pneuma Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00682500 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children |
| Estimated Enrollment: | 480 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
| 2: Placebo Comparator |
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
|
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: | 1 Month to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Traul, MD | 434-982-3973 | CT6Q@hscmail.mcc.virginia.edu |
| Contact: Douglas Willson, MD | 434-982-1707 | dfw4m@virginia.edu |
Hide Study Locations| United States, Florida | |
| Florida Hospital and Florida Children's Hospital | Recruiting |
| Orlando, Florida, United States | |
| Contact: Aaron Godshall ajg@floridapediatrics.com | |
| Contact: Corina Mattix cmattix@seclinical.com | |
| Principal Investigator: Aaron Godshall, MD | |
| Principal Investigator: Michael Rodricks, MD | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States | |
| Contact: Melissa Lamb 352-392-1224 lambm@peds.ufl.edu | |
| Principal Investigator: Irina Ten, MD | |
| Principal Investigator: Eloise Harman, MD | |
| United States, Illinois | |
| Northwestern University-Chicago | Recruiting |
| Chicago, Illinois, United States | |
| Contact: Helen Donnelly, RN 312-695-1881 h-donnelly@northwestern.edu | |
| Principal Investigator: Sarice Bassin, MD | |
| Principal Investigator: Richard Wunderink, MD | |
| West Suburban Hospital Medical Center | Recruiting |
| Oak Park, Illinois, United States | |
| Contact: Kelly Maple, RN 708-763-6757 kelly.maple@reshealthcare.org | |
| Principal Investigator: Tony Marinelli, MD | |
| Peoria Pulmonary Associates/OSF St. Francis Hospital | Not yet recruiting |
| Peoria, Illinois, United States | |
| Contact: Kimberly Hartwig khartwig@ppagroup.com | |
| Principal Investigator: William Tillis, MD | |
| United States, Indiana | |
| Clarian Health, Inc/Methodist Hospital | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Christopher Naum cnaum@clarian.org | |
| Contact: Annie Thorp athorp2@clarian.org | |
| Principal Investigator: Christopher Naum, MD | |
| Riley Children's Hospital/Indiana University | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Lisa Bendy, RRT 317-274-3201 lbendy@iupui.edu | |
| Contact: Kris Bysani, MD 317-274-7208 gbysani@iupui.edu | |
| Principal Investigator: Kris Bysani, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States | |
| Contact: Emily Birrer | |
| Principal Investigator: Gregory Schmidt, MD | |
| United States, Nebraska | |
| Omaha Children's Hospital | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Machelle Zink, RN 402-559-5698 mazink@unmc.edu | |
| Contact: Ed Truemper, MD etruemper@chsomaha.org | |
| Principal Investigator: Ed Truemper, MD | |
| Creighton University | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| Contact: Amy Keyes, RRT Amykeyes@creighton.edu | |
| Contact: Lee Morrow, MD leemorrow@creighton.edu | |
| Principal Investigator: Lee Morrow, MD | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States | |
| Contact: Dean Jarvis, BSN, MBA 603-653-3756 j.dean.jarvis@hitchcock.org | |
| Principal Investigator: Harold Manning, MD | |
| United States, New York | |
| Weill Cornell Medical Center | Recruiting |
| New York, New York, United States | |
| Contact: Mary Yeostas 646-962-2672 mey2003@med.cornell.edu | |
| Contact: Charlene Correa 212-746-3089 csc2004@med.cornell.edu | |
| Principal Investigator: Steven Pon, MD | |
| Principal Investigator: David Berlin, MD | |
| Columbia Medical Center--Pediatrics | Recruiting |
| New York, New York, United States | |
| Contact: Naresh Talathoti, MBBS nt2045@columbia.edu | |
| Principal Investigator: Katherine Biagas, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Becky Gunn, RN 513-636-5860 becky.gunn@cchmc.org | |
| Contact: Sue Poynter, MD sue.poynter@cchmc.org | |
| Principal Investigator: Sue Poynter, MD | |
| Sub-Investigator: Derek Wheeler, MD | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States | |
| Contact: Patsy Guittar, RN, BSN 614-722-2650 patsy.guittar@nationwidechildrens.org | |
| Principal Investigator: Margaret Chase, MD | |
| University of Cincinnati Medical Center | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Chris Blakeman, RRT 513-558-0514 blakemtc@UCMAIL.UC.EDU | |
| Principal Investigator: Gina Dorlac, MD | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States | |
| Contact: Anita Kapil 614-366-1388 anita.kapil@osumc.edu | |
| Principal Investigator: James O'Brien, MD | |
| United States, Oregon | |
| The Oregon Clinic | Recruiting |
| Portland, Oregon, United States | |
| Contact: Kim LaMorticella, BS 503-963-3031 klamorticella@orclinic.com | |
| Principal Investigator: Rhett Cummings, MD | |
| United States, Pennsylvania | |
| Penn State University | Recruiting |
| Hershey, Pennsylvania, United States | |
| Contact: Sarah Sturgis, MSN 717-531-7762 ssturgis@psu.edu | |
| Principal Investigator: Neal Thomas, MD | |
| Principal Investigator: Sandra Blosser, MD | |
| United States, Texas | |
| Baylor College of Medicine/Texas Children's Hospital | Recruiting |
| Houston, Texas, United States | |
| Contact: Nancy Jaimon 832-826-6279 nxjaimon@texaschildrenshospital.org | |
| Principal Investigator: Laura Loftis, MD | |
| Uthscsa/Stvah | Not yet recruiting |
| San Antonio, Texas, United States | |
| Contact: Timothy Houlihan | |
| Principal Investigator: Antonio Anzueto, MD | |
| United States, Virginia | |
| University of Virginia Health Science Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Douglas Willson, MD 434-982-1707 dfw4m@hscmail.mcc.virginia.edu | |
| Contact: Christine Traul, MD 434-982-3973 CT6Q@hscmail.mcc.virginia.edu | |
| Principal Investigator: Douglas Willson, MD | |
| Principal Investigator: Ajeet Vinayak, MD | |
| INOVA Fairfax Hospital | Recruiting |
| Fairfax, Virginia, United States | |
| Contact: Kathi Huddleston, RRT, PhD 703-776-2010 | |
| Principal Investigator: Keith Dockery, MD | |
| Principal Investigator: James Lamberti, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States | |
| Contact: Katherine Luther 414-955-2377 | |
| Contact: Randi Rothman 414-456-6987 | |
| Principal Investigator: Michael Quasney, MD | |
| Principal Investigator: Rahul Nanchal, MD | |
| Australia, New South Wales | |
| Children's Hospital at Westmead | Not yet recruiting |
| Westmead, New South Wales, Australia | |
| Contact: Marino Festa, MD | |
| Contact: Jennifer Drayton | |
| Principal Investigator: Marino Festa, MD | |
| Australia, Northern Territory | |
| Royal Darwin Hospital | Recruiting |
| Darwin, Northern Territory, Australia | |
| Contact: Dianne Stephens, MD | |
| Contact: Jane Thomas jane.thomas@nt.gov.au | |
| Principal Investigator: Dianne Stephens, MBBS | |
| Australia, South Australia | |
| Woman and Children's Hospital | Not yet recruiting |
| Adelaide, South Australia, Australia | |
| Contact: Michael Yung, MD | |
| Principal Investigator: MIchael Yung, MD | |
| Royal Adelaide Hospital | Not yet recruiting |
| Adelaide, South Australia, Australia | |
| Contact: Stuart Baker | |
| Contact: Stephanie O'Connor | |
| Principal Investigator: Stuart Baker, MD | |
| Sub-Investigator: Marianne Chapman, MD | |
| Australia, Victoria | |
| Royal Children's Hospital | Not yet recruiting |
| Parkville, Victoria, Australia | |
| Contact: Warwick Butt, MD | |
| Contact: Carmel Delzoppo | |
| Principal Investigator: Warwick Butt, MD | |
| Australia, Western Australia | |
| Princess Margaret Hospital | Recruiting |
| Fremantle, Western Australia, Australia | |
| Contact: Simon Erickson, MD | |
| Principal Investigator: Simon Erickson, MD | |
| Fremantle Hospital | Not yet recruiting |
| Fremantle, Western Australia, Australia | |
| Contact: Daivd Blythe, MD | |
| Contact: Anne Marie Palermo | |
| Principal Investigator: David Blythe, MD | |
| Royal Perth Hospital | Not yet recruiting |
| Perth, Western Australia, Australia | |
| Contact: Geoffry Dobb, MD | |
| Contact: Jenny Chamberlain | |
| Principal Investigator: Geoffry Dobb, MD | |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Maureen Gardner 604-875-4111 x68631 maureen.gardner@vch.ca | |
| Principal Investigator: Juan Ronco, MD | |
| British Columbia Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Gordon Krahn, RRT 604-875-2345 x 5962 gkrahn@cw.bc.ca | |
| Principal Investigator: David Wensley, MD | |
| Royal Columbian Hospital | Not yet recruiting |
| New Westminster, British Columbia, Canada | |
| Contact: Miroslav Svetik | |
| Principal Investigator: Steven Reynolds, MD | |
| Canada, Ontario | |
| Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Tracy McArdle 613-737-8823 | |
| Principal Investigator: Gwynne Jones, MD | |
| London Health Sciences Center | Not yet recruiting |
| London, Ontario, Canada | |
| Contact: Theresa Morrison | |
| Principal Investigator: Claudio Martin, MD | |
| Kingston General Hospital | Not yet recruiting |
| Kingston, Ontario, Canada | |
| Contact: John Muscedere, MD | |
| Contact: Susan Fleury | |
| Principal Investigator: John Muscedere, MD | |
| Canada, Quebec | |
| Ste. Justine Medical Center | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Nicole Poitras nicole.poitras@recherche-ste-justine.qc.ca | |
| Principal Investigator: Philippe Jouvet, MD | |
| Laval Hospital | Recruiting |
| Quebec City, Quebec, Canada | |
| Contact: Marie-Claude Ferland 418-656-8711 ext 3937 | |
| Principal Investigator: Francois Lellouche, MD | |
| Rosemont Massoneuve Hospital | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Johanne Harvey 514-252-3400 ext 4679 | |
| Principal Investigator: Brian Laufer, MD | |
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| New Zealand | |
| Starship Children's Hospital | Recruiting |
| Auckland, New Zealand | |
| Contact: John Beca, MD | |
| Contact: Laura Whelan | |
| Principal Investigator: John Beca, MD | |
| New Zealand, Auckland | |
| Auckland City Hospital | Recruiting |
| Auckland City, Auckland, New Zealand | |
| Contact: Colin McArthur | |
| Contact: Lynette Newby | |
| Principal Investigator: Colin McArthur, MD | |
| Study Chair: | Douglas Willson, MD | Univeristy of Virginia Health Sciences Center |
| Study Chair: | Jonathon Truwit, MD | University of Virginia Health Sciences Center |
More Information
| Responsible Party: | University of Virginia Health Science Center ( Douglas Willson, MD ) |
| Study ID Numbers: | Pneuma AR-06 |
| Study First Received: | May 20, 2008 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00682500 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pneumonia Aspiration Drowning inhalation |
|
Respiratory System Agents Pathologic Processes Disease Respiratory Tract Diseases Therapeutic Uses Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult Calfactant Pharmacologic Actions Pulmonary Surfactants |
