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

This study is currently recruiting participants.

Verified by Novartis, September 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00084071

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 III

MedlinePlus related topics: Pneumonia

Drug Information available for: Thromboplastin Tifacogin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

Further study details as provided by Novartis:

Primary Outcome Measures:

Compare the effect of tifacogin vs placebo administration.

Estimated Enrollment:	2100
Study Start Date:	May 2004
Estimated Study Completion Date:	March 2009

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

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

Contacts

Contact: Novartis

1-862-778-8300

Show 152 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CTFP561A2308
Study First Received:	June 4, 2004
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00084071
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipoprotein-associated coagulation inhibitor
Respiratory Tract Infections
Respiratory Tract Diseases

Thromboplastin
Lung Diseases
Pneumonia

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009