Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia

NCT ID: NCT00084071

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tifacogin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
* Pneumonia of sufficient severity to require ICU admission and management

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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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, 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, 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, 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, Australia

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Heidelburg, Victoria, Australia

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Parkville, Victoria, Australia

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Nedlands, Western Australia, 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

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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, , 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

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Countries

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Philippines United States Argentina Australia Belgium Brazil Canada Chile France Germany Malaysia Netherlands New Zealand Peru Singapore South Africa South Korea Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19284881 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3160

Results for CTFP561A2308 from the Novartis Clinical Trials website

Other Identifiers

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CTFP561A2308

Identifier Type: -

Identifier Source: org_study_id