HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia.

AbstractINTRODUCTION:
The purpose of this analysis was to determine the potential efficacy of recombinant human tissue factor pathway inhibitor (tifacogin) in a subpopulation of patients with community-acquired pneumonia (CAP) from a phase III study of severe sepsis.
METHODS:
A retrospective review of patients with suspected pneumonia was conducted by an independent clinical evaluation committee (CEC) blinded to treatment assignment. The CEC reanalyzed data from patients enrolled in an international multicenter clinical trial of sepsis who had a diagnosis of pneumonia as the probable source of sepsis. The primary efficacy measure was all-cause 28-day mortality.
RESULTS:
Of 847 patients identified on case report forms with a clinical diagnosis of pneumonia, 780 (92%) were confirmed by the CEC to have pneumonia. Of confirmed pneumonia cases, 496 (63.6%) met the definition for CAP. In the CEC CAP population, the mortality rates of the tifacogin and placebo groups were 70/251 (27.9%) and 80/245 (32.7%), respectively. The strongest signals were seen in patients with CAP not receiving concomitant heparin, having microbiologically confirmed infection, or having the combination of documented infection and no heparin. The reduction in mortality in this narrowly defined subgroup when treated with tifacogin compared with placebo was statistically significant (17/58 [29.3%] with tifacogin and 28/54 [51.9%] with placebo; unadjusted P value of less than 0.02).
CONCLUSIONS:
Tifacogin administration did not significantly reduce mortality in any severe CAP patient. Exploratory analyses showed an improved survival in patients who did not receive concomitant heparin with microbiologically confirmed infections. These data support the rationale of an ongoing phase III study exploring the potential benefit of tifacogin in severe CAP.
TRIAL REGISTRATION:
ClinicalTrials.gov identifier NCT00084071.
AuthorsPierre-François Laterre, Steven M Opal, Edward Abraham, Steven P LaRosa, Abla A Creasey, Fang Xie, Lona Poole, Richard G Wunderink
JournalCritical care (London, England) (Crit Care) Vol. 13 Issue 2 Pg. R36 ( 2009) ISSN: 1466-609X [Electronic] England
PMID19284881 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Proteins
  • Tifacogin
Topics
  • APACHE
  • Aged
  • Clinical Trials, Phase III as Topic
  • Community-Acquired Infections (drug therapy)
  • Female
  • Gram-Negative Aerobic Bacteria (isolation & purification)
  • Gram-Positive Bacteria (isolation & purification)
  • Humans
  • Male
  • Middle Aged
  • Pneumonia, Bacterial (drug therapy, microbiology)
  • Proteins (administration & dosage, pharmacology, therapeutic use)
  • Retrospective Studies
  • Survival Analysis
  • Treatment Outcome

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: