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

Overview

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

Full Title of Study: “Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: July 2008

Interventions

  • Drug: Tifacogin

Clinical Trial Outcome Measures

Primary Measures

  • Compare the effect of tifacogin vs placebo administration.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Novartis Pharmaceuticals
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Novartis, Study Director, Novartis

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