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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00084071
Recruitment Status : Completed
First Posted : June 8, 2004
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Tifacogin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia
Study Start Date : May 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Compare the effect of tifacogin vs placebo administration.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00084071

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00084071     History of Changes
Other Study ID Numbers: CTFP561A2308
First Posted: June 8, 2004    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lipoprotein-associated coagulation inhibitor
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors