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

December 11, 2020 updated by: Novartis Pharmaceuticals

Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina
      • Tandil, Buenos Aires, Argentina
      • Tres De Febrero, Buenos Aires, Argentina
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Camperdown, New South Wales, Australia
      • Kingswood, New South Wales, Australia
    • Queensland
      • Cairns, Queensland, Australia
      • Nambour, Queensland, Australia
      • Southport, Queensland, Australia, 4215
    • South Australia
      • Woodville, South Australia, Australia
    • Tasmania
      • Hobart, Tasmania, Australia
      • Launceston, Tasmania, Australia
    • Victoria
      • Box Hill, Victoria, Australia
      • Footscray, Victoria, Australia, 3011
      • Heidelburg, Victoria, Australia, 3084
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
      • Perth, Western Australia, Australia
  • Belgium
      • Bouge, Belgium
      • Braine l'Alleud, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Liege, Belgium
      • Mons, Belgium
      • Ottignies, Belgium
      • Seraing, Belgium
      • Yvoir, Belgium
    • Jette
      • Brussels, Jette, Belgium
  • Brazil
    • BA
      • Salvador, BA, Brazil
        • Belgium
      • Salvador, BA, Brazil
    • CE
      • Fortaleza, CE, Brazil
    • PE
      • Recife, PE, Brazil
    • PR
      • Curitiba, PR, Brazil
    • RS
      • Pelotas, RS, Brazil
      • Porto Alegre, RS, Brazil
    • SC
      • Florianopolis, SC, Brazil
    • SP
      • Campinas, SP, Brazil
      • Sao Jose do Rio Preto, SP, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Montreal, Quebec, Canada
  • Chile
      • Santiago de Chile, Chile
      • Temuco, Chile
  • France
      • Argenteuil, France
      • Belfort, France
      • Besancon, France
      • La Roche Sur Yoon, France
      • Limoges, France
      • Paris, France
      • Pierre Benite, France
      • Saint Michel, France
      • Tours, France
  • Germany
      • Luebeck, Germany
      • Munchen, Germany, 81545
      • Regensburg, Germany
  • Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Gyunggi, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of
    • Incheon
      • Namdong-gu, Incheon, Korea, Republic of
  • Malaysia
      • Johor Bahru, Malaysia
      • Kota Bharu Kelantan, Malaysia
      • Kuala Lumpar, Malaysia
      • Penang, Malaysia
      • Selangor, Malaysia
  • Netherlands
      • Hertogenbosch, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
  • New Zealand
      • Christchurch, New Zealand
      • Hastings, New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
      • Otahuhu, Auckland, New Zealand
  • Peru
      • Lima, Peru
  • Singapore
      • Singapore, Singapore
  • South Africa
      • Bloemfontein, South Africa
      • Centurion, South Africa
      • Kimberley, South Africa
      • Parktown West, South Africa
    • Durban
      • Congella, Durban, South Africa
    • Johannesburg
      • Parktown, Johannesburg, South Africa
  • Spain
      • Madrid, Spain
      • Palma de Mallorca, Spain
      • Santiago de Compostela, Spain
    • Barcelona
      • Sabadell, Barcelona, Spain
  • United Kingdom
      • Glasgow, United Kingdom
      • Livingston, United Kingdom
      • London, United Kingdom
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • California
      • Loma Linda, California, United States
      • Los Angeles, California, United States
      • Orange, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Jose, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Farmington, Connecticut, United States
      • New Haven, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Clearwater, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Conyers, Georgia, United States
      • Decatur, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Park, Illinois, United States
    • Indiana
      • Muncie, Indiana, United States
      • New Albany, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Cumberland, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
      • Southfield, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • Nevada
      • Reno, Nevada, United States
    • New York
      • Buffalo, New York, United States
      • Johnson City, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
      • Providence, Rhode Island, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Winchester, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare the effect of tifacogin vs placebo administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 4, 2004

First Submitted That Met QC Criteria

June 7, 2004

First Posted (Estimate)

June 8, 2004

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTFP561A2308

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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