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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00084071
First received: June 4, 2004
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Pneumonia
Drug: Tifacogin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Enrollment: 2136
Study Start Date: May 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084071

  Show 150 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00084071     History of Changes
Other Study ID Numbers: CTFP561A2308
Study First Received: June 4, 2004
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lipoprotein-associated coagulation inhibitor
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014