Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

CompletadoFase 3ClinicalTrials.gov

ID: NCT00568737Tipo: INTERVENTIONALInicio: 1 de nov de 2002Fin estimado: 1 de feb de 2005

Traducción no disponible, mostrando original

Resumen

Adult Patients with Severe Sepsis

Descripción detallada

Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score \<25 or single organ dysfunction).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.

Criterios de exclusión

Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
Platelet count less than 30,000/mm3.

Intervenciones

drug

Drotrecogin alfa (activated)

Drotrecogin Alfa (activated)

drug

Placebo

0.9% sodium chloride

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Haedi, Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Monte Grande, Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Rosario - Santa Fe, Buenos Aires, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Córdoba, Córdoba Province, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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