Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
1 other identifier
interventional
2,136
18 countries
150
Brief Summary
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Typical duration for phase_3
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 4, 2004
CompletedFirst Posted
Study publicly available on registry
June 8, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedDecember 19, 2020
July 1, 2012
4.2 years
June 4, 2004
December 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the effect of tifacogin vs placebo administration.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
- Pneumonia of sufficient severity to require ICU admission and management
You may not qualify if:
- Pregnancy
- Weight over 150 kg
- Patients at increased risk of bleeding
- Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa
- Treatment with heparin or anticipated need for heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (150)
Unknown Facility
Mobile, Alabama, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Bay Pines, Florida, 33744, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Muncie, Indiana, United States
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New Albany, Indiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Cumberland, Maryland, United States
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Detroit, Michigan, United States
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Southfield, Michigan, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Reno, Nevada, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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Greensboro, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Allentown, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Winchester, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Mar del Plata, Buenos Aires, Argentina
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Tandil, Buenos Aires, Argentina
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Tres de Febrero, Buenos Aires, Argentina
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Capital Federal, Argentina
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Garran, Australian Capital Territory, 2605, Australia
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Camperdown, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Cairns, Queensland, Australia
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Nambour, Queensland, Australia
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Southport, Queensland, 4215, Australia
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Woodville, South Australia, Australia
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Hobart, Tasmania, Australia
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Launceston, Tasmania, Australia
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Box Hill, Victoria, Australia
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Footscray, Victoria, 3011, Australia
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Heidelburg, Victoria, 3084, Australia
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Parkville, Victoria, 3050, Australia
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Nedlands, Western Australia, 6009, Australia
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Perth, Western Australia, Australia
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Brussels, Jette, Belgium
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Bouge, Belgium
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Braine-l'Alleud, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Liège, Belgium
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Mons, Belgium
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Ottignies, Belgium
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Seraing, Belgium
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Yvoir, Belgium
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Fortaleza, Ceará, Brazil
Belgium
Salvador, Estado de Bahia, Brazil
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Pelotas, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Campinas, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Santiago, Chile
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Temuco, Chile
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Argenteuil, France
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Belfort, France
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Besançon, France
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La Roche Sur Yoon, France
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Limoges, France
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Paris, France
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Pierre-Bénite, France
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Saint-Michel, France
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Tours, France
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Lübeck, Germany
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München, 81545, Germany
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Regensburg, Germany
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George Town, Malaysia
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Johor Bahru, Malaysia
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Kota Bharu Kelantan, Malaysia
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Kuala Lumpar, Malaysia
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Kuala Selangor, Malaysia
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's-Hertogenbosch, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Grafton, Auckland, New Zealand
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Otahuhu, Auckland, New Zealand
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Christchurch, New Zealand
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Hastings, New Zealand
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Lima, Peru
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Singapore, Singapore
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KwaKhangela, Durban, South Africa
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Parktown, Johannesburg, South Africa
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Bloemfontein, South Africa
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Centurion, South Africa
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Kimberley, South Africa
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Parktown West, South Africa
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Wŏnju, Gangwon-do, South Korea
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Namdong-gu, Incheon, South Korea
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Gyeonggi-do, South Korea
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Gyunggi, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Sabadell, Barcelona, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Santiago de Compostela, Spain
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Glasgow, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
Related Publications (1)
Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.
PMID: 19284881DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2004
First Posted
June 8, 2004
Study Start
May 1, 2004
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
December 19, 2020
Record last verified: 2012-07