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

Novartis

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Tifacogin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00084071

CTFP561A2308

Details and patient eligibility

About

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

Enrollment: 2,136 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind