Repositorio UFRO · Omeka S

High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial

Co-autores	Valdivieso, Francisca Ferres, Marcela Riquelme, Raul Luisa Rioseco, M. Calvo, Mario Castillo, Constanza Diaz, Ricardo Scholz, Luis Cuiza, Analia Belmar, Edith Hernandez, Carla Martinez, Jessica Lee, Sang-Joon Mertz, Gregory J.
Título	High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial
Editorial	OXFORD UNIV PRESS INC
Revista	CLINICAL INFECTIOUS DISEASES
Lenguaje	en
Resumen	Background. Andes virus (ANDV)-related hantavirus cardiopulmonary syndrome (HCPS) has a 35% case fatality rate in Chile and no specific treatment. In an immunomodulatory approach, we evaluated the efficacy of intravenous methylprednisolone for HCPS treatment, through a parallel-group, placebo-controlled clinical trial. Methods. Patients aged >2 years, with confirmed or suspected HCPS in cardiopulmonary stage, admitted to any of 13 study sites in Chile, were randomized by study center in blocks of 4 with a 1: 1 allocation and assigned through sequentially numbered envelopes to receive placebo or methylprednisolone 16 mg/kg/day (<= 1000 mg) for 3 days. All personnel remained blinded except the local pharmacist. Infection was confirmed by immunoglobulin M antibodies or ANDV RNA in blood. The composite primary endpoint was death, partial pressure of arterial oxygen/fraction of inspired oxygen ratio <= 55, cardiac index <= 2.2, or ventricular tachycardia or fibrillation within 28 days. Safety endpoints included the number of serious adverse events (SAEs) and quantification of viral RNA in blood. Analysis was by intention to treat. Results. Infection was confirmed in 60 of 66 (91%) enrollees. Fifteen of 30 placebo-treated patients and 11 of 30 methylprednisolone-treated patients progressed to the primary endpoint (P = .43). We observed no significant difference in mortality between treatment groups (P = .41). There was a trend toward more severe disease in placebo recipients at entry. More subjects in the placebo group experienced SAEs (P = .02). There were no SAEs clearly related to methylprednisolone administration, and methylprednisolone did not increase viral load. Conclusions. Although methylprednisolone appears to be safe, it did not provide significant clinical benefit to patients. Our results do not support the use of methylprednisolone for HCPS.
Tipo de Recurso	Artículo original
Description	This work was supported by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (grant number 5U19AI045452). Este trabajo fue financiado por el Instituto Nacional de Alergias y Enfermedades Infecciosas de los Institutos Nacionales de Salud (subvención número 5U19AI045452).
doi	10.1093/cid/cit394
Formato Recurso	pdf
Palabras Claves	hantavirus hantavirus cardiopulmonary syndrome hantavirus pulmonary syndrome methylprednisolone clinical trial TO-PERSON TRANSMISSION PULMONARY SYNDROME HEMORRHAGIC-FEVER GENETIC IDENTIFICATION RIBAVIRIN THERAPY ANDES VIRUS CELLS PATHOGENESIS RESPONSES OUTBREAK hantavirus síndrome cardiopulmonar por hantavirus síndrome pulmonar por hantavirus metilprednisolona ensayo clínico TRANSMISIÓN DE PERSONA A PERSONA SÍNDROME PULMONAR FIEBRE HEMORRÁGICA IDENTIFICACIÓN GENÉTICA TERAPIA CON RIBAVIRINA VIRUS ANDES CÉLULAS PATOGÉNESIS RESPUESTAS BROTE
Ubicación del archivo	http://dx.doi.org/10.1093/cid/cit394
Materias	hantavirus hantavirus cardiopulmonary syndrome hantavirus pulmonary syndrome methylprednisolone clinical trial TO-PERSON TRANSMISSION PULMONARY SYNDROME HEMORRHAGIC-FEVER GENETIC IDENTIFICATION RIBAVIRIN THERAPY ANDES VIRUS CELLS PATHOGENESIS RESPONSES OUTBREAK hantavirus síndrome cardiopulmonar por hantavirus síndrome pulmonar por hantavirus metilprednisolona ensayo clínico TRANSMISIÓN DE PERSONA A PERSONA SÍNDROME PULMONAR FIEBRE HEMORRÁGICA IDENTIFICACIÓN GENÉTICA TERAPIA CON RIBAVIRINA VIRUS ANDES CÉLULAS PATOGÉNESIS RESPUESTAS BROTE
Disciplinas de la OCDE	Enfermedades Infecciosas Medicina de Emergencia y de Cuidados Críticos Medicina General e Interna
Título de la cita (Recomendado-único)	High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial
Revista/Libro	CLINICAL INFECTIOUS DISEASES
Tipo de ruta	hibrida verde
Access Rights	acceso abierto
Derechos de acceso	acceso abierto
Identificador alternativo	PMID 23784924
Idioma	en
Identificador del recurso (Mandatado-único)	Artículo original
Versión del recurso (Recomendado-único)	versión publicada
Entidad financiadora	National Institute of Allergy and Infectious Diseases at the National Institutes of Health 5U19AI045452
Referencia del Financiador (Mandatado si es aplicable-repetible)	National Institute of Allergy and Infectious Diseases at the National Institutes of Health 5U19AI045452
Editorial	OXFORD UNIV PRESS INC
ISSN	1058-4838
Página de inicio (Recomendado-único)	943
Página final (Recomendado-único)	951
Categoría WOS	Inmunología Enfermedades infecciosas Microbiología Immunology Infectious Diseases Microbiology
Formato	pdf
Id de Web of Science	WOS:000326027400006