NEWS HIGHLIGHTSMedia Articles Related to Xigris (Drotrecogin Alfa)
Surviving Sepsis Program -- Increased Compliance Gets Results
Source: Compliance News From Medical News Today [2009.09.03]
A 'surviving sepsis' in-hospital project has been shown to improve the care of patients with sepsis. The educational program for early management of patients with septic shock, described in BioMed Central's open access journal Critical Care, increased compliance with sepsis guidelines and led to a 45% risk reduction for in-hospital death. Massimo Girardis led a team of researchers from the University Hospital of Modena who carried out the study.
Neonatal Sepsis (Sepsis Neonatorum)
Source: MedicineNet Chlamydia In Women Specialty [2009.03.04]
Title: Neonatal Sepsis (Sepsis Neonatorum)
Category: Doctor's Views
Created: 3/4/2009
Last Editorial Review: 3/4/2009
Compound Shows Potential For Slowing Progression Of ALS
Source: Muscular Dystrophy / ALS News From Medical News Today [2009.10.20]
A chemical cousin of a drug currently used to treat sepsis dramatically slows the progression of amyotrophic lateral sclerosis, better known as ALS or Lou Gehrig's disease, in mice. The results offer a bit of good news in efforts to develop a therapy to stop or slow the progression of a disease that generally kills its victims within just a few years. In a paper published online Oct.
Published Studies Related to Xigris (Drotrecogin Alfa)
A retrospective observational study of drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial. [2008.01]
OBJECTIVE:: To compare characteristics and outcomes of patients treated with drotrecogin alfa (activated) (DrotAA) in clinical practice to those treated in a phase III randomized controlled trial (PROWESS)... CONCLUSIONS:: Patients treated in clinical practice differed from those in PROWESS. Patients were younger, had more comorbidities, had greater severity of illness, and had longer mean time from severe sepsis onset to the start of DrotAA. Hospital mortality for patients treated within 1 day of severe sepsis onset was similar to DrotAA-treated PROWESS patients. While the low number of serious bleeding events precludes a definitive assessment, the observed incidence of serious bleeding events in clinical practice patients was numerically higher than in DrotAA-treated PROWESS patients.
My brother has severe sepsis Should he receive Xigris(R)? [2007.12]
Six years ago, a publication in a quite well known scientific medical journal brought hope and a good dose of optimism to sepsis therapy and the critical care community. For the first time, a careful randomized controlled trial in patients with severe sepsis or septic shock seemed to show a clearly beneficial effect of a new drug, i.e...
Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated). [2007.09.01]
RATIONALE: Patients with severe sepsis frequently receive prophylactic heparin during drotrecogin alfa (activated) (DrotAA) treatment due to risk of venous thromboembolic events (VTEs). Biological plausibility exists for heparin to reduce DrotAA efficacy and/or increase bleeding. OBJECTIVES: Primary: demonstrate in adult patients with severe sepsis receiving DrotAA treatment that 28-day mortality was equivalent for patients treated with concomitant prophylactic heparin compared with placebo; secondary: safety and VTE incidence... CONCLUSIONS: Compared with placebo, concomitant prophylactic heparin was not equivalent, did not increase 28-day mortality, and had an acceptable safety profile in patients with severe sepsis receiving DrotAA. Heparin discontinuation should be carefully weighed in patients considered for DrotAA treatment. XPRESS clinical trial registered with www.clinicaltrials.gov (NCT 00049777). The study ID numbers are 6743; F1K-MC-EVBR.
Drotrecogin alfa (activated) in the treatment of severe sepsis. [2007.09]
Severe sepsis and septic shock are common in the critically ill patient and account for considerable morbidity and mortality not to mention the high associated costs. Advances in our understanding of sepsis pathophysiology and in the important link between the inflammatory response to sepsis and activation of coagulation led to the development and licensing of the first ever, specific, immunomodulatory anti-sepsis drug...
Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. [2007.03.10]
BACKGROUND: Drotrecogin alfa (activated) (DrotAA) is used for the treatment of adults with severe sepsis who have a high risk of dying. A phase 1b open-label study has indicated that the pharmacokinetics and pharmacodynamics of DrotAA are similar in children and adults. We initiated the RESOLVE (REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspectiVE) trial to investigate the efficacy and safety of the drug in children... INTERPRETATION: Although we did not record any efficacy of DrotAA in children with severe sepsis, serious bleeding events were similar between groups and the overall safety profile acceptable, except in children younger than 60 days. However, we gained important insights into clinical and laboratory characteristics of childhood severe sepsis, and have identified issues that need to be addressed in future trials in critically ill children.
Clinical Trials Related to Xigris (Drotrecogin Alfa)
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis [Completed]
The purposes of this study are to determine:
1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their
condition more often or recover faster than children who do not receive drotrecogin alfa
(activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with
severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated)
administration to children with severe sepsis.
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study [Completed]
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation [Completed]
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood
cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for
bone marrow transplant (BMT).
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated) [Recruiting]
Protein C is a protein that is involved in your body's ability to clot blood. In this trial,
patients with severe sepsis and low protein C levels will receive drotrecogin alfa
(activated) at the normal, approved dose and time of administration [24mcg/kg/hour for 96
hours] or will receive the normal, approved dose or higher doses than the approved dose for a
longer administration time. After the drug administration is complete, the protein C levels
from the patients receiving the normal, approved dose will be compared to protein C levels
from patients receiving the normal, approved dose or higher dose for a longer duration to
determine if the protein C levels improve faster if given higher dose and/or longer
administration time.
Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion [Completed]
The purpose of this study is to determine whether continued administration of Drotrecogin
Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.
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