Tifacogin 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.

Completed

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mar del Plata, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tifacogin

Drug

Primary outcomes

Compare the effect of tifacogin vs placebo administration.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Jun 8, 2004
Registry last updated: Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed