Back to resultsTifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tifacogin
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
Eligibility Criteria
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
Sites / Locations
- Belgium
Outcomes
Primary Outcome Measures
Compare the effect of tifacogin vs placebo administration.
Secondary Outcome Measures
Full Information
NCT ID
NCT00084071
First Posted
June 4, 2004
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00084071
Brief Title
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
Official Title
Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2136 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tifacogin
Primary Outcome Measure Information:
Title
Compare the effect of tifacogin vs placebo administration.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Loma Linda
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
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United States
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Orange
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California
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United States
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Sacramento
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California
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United States
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San Diego
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California
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United States
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San Jose
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California
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United States
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Denver
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Colorado
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United States
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Farmington
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Connecticut
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United States
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New Haven
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Connecticut
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United States
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Newark
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Delaware
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United States
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Bay Pines
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Florida
ZIP/Postal Code
33744
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United States
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Clearwater
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Florida
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United States
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Fort Lauderdale
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Florida
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United States
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Jacksonville
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United States
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Atlanta
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Georgia
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United States
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Conyers
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Georgia
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United States
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Decatur
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Georgia
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United States
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Chicago
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Illinois
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United States
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Oak Park
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Illinois
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United States
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Muncie
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Indiana
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United States
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New Albany
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Indiana
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United States
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Shreveport
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Louisiana
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United States
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Baltimore
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Maryland
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United States
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Cumberland
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Maryland
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United States
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Detroit
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Michigan
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United States
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Southfield
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Michigan
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United States
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Saint Louis
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Missouri
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United States
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Butte
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Montana
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United States
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Reno
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Nevada
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United States
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Buffalo
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New York
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United States
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Johnson City
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New York
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United States
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Greensboro
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North Carolina
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United States
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Winston-Salem
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North Carolina
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United States
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Cincinnati
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Ohio
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United States
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Columbus
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United States
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Toledo
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Allentown
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Pennsylvania
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United States
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Pawtucket
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Rhode Island
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United States
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Providence
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Rhode Island
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United States
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Spartanburg
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South Carolina
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United States
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Knoxville
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Tennessee
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United States
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Dallas
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United States
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San Antonio
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United States
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Tyler
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Texas
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United States
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Salt Lake City
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Utah
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United States
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Norfolk
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Virginia
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United States
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Winchester
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Virginia
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United States
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Seattle
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Washington
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United States
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Tacoma
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Washington
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United States
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Mar del Plata
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Buenos Aires
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Argentina
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Tandil
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Buenos Aires
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Argentina
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Tres De Febrero
State/Province
Buenos Aires
Country
Argentina
City
Capital Federal
Country
Argentina
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Camperdown
State/Province
New South Wales
Country
Australia
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Kingswood
State/Province
New South Wales
Country
Australia
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Cairns
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Queensland
Country
Australia
City
Nambour
State/Province
Queensland
Country
Australia
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Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
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Woodville
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South Australia
Country
Australia
City
Hobart
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Tasmania
Country
Australia
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Launceston
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Tasmania
Country
Australia
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Box Hill
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Victoria
Country
Australia
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
City
Heidelburg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Perth
State/Province
Western Australia
Country
Australia
City
Brussels
State/Province
Jette
Country
Belgium
City
Bouge
Country
Belgium
City
Braine l'Alleud
Country
Belgium
City
Brussels
Country
Belgium
City
Gent
Country
Belgium
City
Liege
Country
Belgium
City
Mons
Country
Belgium
City
Ottignies
Country
Belgium
City
Seraing
Country
Belgium
City
Yvoir
Country
Belgium
Facility Name
Belgium
City
Salvador
State/Province
BA
Country
Brazil
City
Salvador
State/Province
BA
Country
Brazil
City
Fortaleza
State/Province
CE
Country
Brazil
City
Recife
State/Province
PE
Country
Brazil
City
Curitiba
State/Province
PR
Country
Brazil
City
Pelotas
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RS
Country
Brazil
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Porto Alegre
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RS
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Brazil
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Florianopolis
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SC
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Brazil
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Campinas
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SP
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Brazil
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Sao Jose do Rio Preto
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SP
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Brazil
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Calgary
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Alberta
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Canada
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Edmonton
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Alberta
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Canada
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New Westminster
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British Columbia
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Canada
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Surrey
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British Columbia
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Canada
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Vancouver
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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Winnipeg
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Manitoba
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Canada
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Hamilton
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Ontario
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Canada
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Kingston
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Ontario
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Canada
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Ottawa
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Greenfield Park
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Quebec
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Canada
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Montreal
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Quebec
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Canada
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Santiago de Chile
Country
Chile
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Temuco
Country
Chile
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Argenteuil
Country
France
City
Belfort
Country
France
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Besancon
Country
France
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La Roche Sur Yoon
Country
France
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Limoges
Country
France
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Paris
Country
France
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Pierre Benite
Country
France
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Saint Michel
Country
France
City
Tours
Country
France
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Luebeck
Country
Germany
City
Munchen
ZIP/Postal Code
81545
Country
Germany
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Regensburg
Country
Germany
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Wonju
State/Province
Gangwon-do
Country
Korea, Republic of
City
Namdong-gu
State/Province
Incheon
Country
Korea, Republic of
City
Gyeonggi-Do
Country
Korea, Republic of
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Gyunggi
Country
Korea, Republic of
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Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
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Johor Bahru
Country
Malaysia
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Kota Bharu Kelantan
Country
Malaysia
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Kuala Lumpar
Country
Malaysia
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Penang
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Malaysia
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Selangor
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Malaysia
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Hertogenbosch
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Netherlands
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Grafton
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Auckland
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New Zealand
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Otahuhu
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hastings
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New Zealand
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Lima
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Peru
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Singapore
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Singapore
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Congella
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Durban
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South Africa
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Parktown
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Johannesburg
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South Africa
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Bloemfontein
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South Africa
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Centurion
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South Africa
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Kimberley
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South Africa
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Parktown West
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South Africa
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Sabadell
State/Province
Barcelona
Country
Spain
City
Madrid
Country
Spain
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Palma de Mallorca
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Glasgow
Country
United Kingdom
City
Livingston
Country
United Kingdom
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19284881
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3160
Description
Results for CTFP561A2308 from the Novartis Clinical Trials website
Learn more about this trial
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia
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