ACCESS: Comparación controlada de eritoran tetrasódico y placebo en pacientes con sepsis grave

CompletadoFase 3ClinicalTrials.gov

ID: NCT00334828Tipo: INTERVENTIONALInicio: 1 de jun de 2006

Resumen

El propósito de este estudio es comparar eritoran tetrasódico con placebo en pacientes con sepsis grave y demostrar una reducción de la mortalidad por todas las causas.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Age \>= 18 years
Confirmed early-onset severe sepsis, defined as:
o---Objective evidence of infection likely to be caused by a bacterial or fungal pathogen
o---Presence of at least 3 of 4 systemic inflammatory response syndrome (SIRS) criteria
o---Sepsis-associated organ dysfunction
Baseline Acute Physiology and Chronic Health Evaluation II (Apache II) Score of 21 to 37
\< 12 hours between onset of the first qualifying organ dysfunction and expected administration of study drug
A commitment to full patient support

Criterios de exclusión

Pregnancy or breastfeeding
Extensive (\>20% Body Surface Area) third-degree burns
Weight \> 150 kg at admission
Patients whose death from sepsis is considered imminent
Patients not expected to survive for at least 2 months due to a pre-existing and uncorrectable medical condition, or those in a chronic vegetative state
Patients with severe congestive heart failure
Patients currently receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer chemotherapy
Patients with granulocyte counts \< 1000/mm\^3 unless the decreased count is believed to be due to sepsis
Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment
Human immunodeficiency virus (HIV)-positive patients with CD4 count \<= 50/mm\^3 within 4 weeks of enrollment, or end-stage processes
Patients with significant hepatic impairment, portal hypertension, or esophageal varices
Patients who are expected to be treated with endotoxin-removal devices
Patients with active cancer
Patients receiving polymyxin B or colistin

Intervenciones

drug

eritoran tetrasodium

Intravenous infusion at a total dose of 105 mg.

drug

Placebo

Matching placebo; intravenous infusion.

Ubicaciones

Buenos Aires, Argentina

Córdoba, Argentina

Santa Fe, Argentina

Patrocinadores

PrincipalEisai Inc.

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