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

Vial, Pablo A. ; Valdivieso, Francisca ; Ferres, Marcela ; Riquelme, Raul ; Rioseco, M. Luisa ; Calvo, Mario ; Castillo, Constanza ; Díaz, Ricardo ; Scholz, Luis ; Cuiza, Analia ; Belmar, Edith ; Hernandez, Carla ; Martinez, Jessica ; Lee, Sang-Joon ; Mertz, Gregory J.

Clinical infectious diseases, 2013-10, Vol.57 (7), p.943-951 [Peer Reviewed Journal]

Oxford: Oxford University Press

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Title:
High-Dose Intravenous Methylprednisolone for Hantavirus Cardiopulmonary Syndrome in Chile: A Double-Blind, Randomized Controlled Clinical Trial
Author: Vial, Pablo A. ; Valdivieso, Francisca ; Ferres, Marcela ; Riquelme, Raul ; Rioseco, M. Luisa ; Calvo, Mario ; Castillo, Constanza ; Díaz, Ricardo ; Scholz, Luis ; Cuiza, Analia ; Belmar, Edith ; Hernandez, Carla ; Martinez, Jessica ; Lee, Sang-Joon ; Mertz, Gregory J.
Subjects: Administration, Intravenous ; Adolescent ; Adult ; and Commentaries ; Anti-Inflammatory Agents - administration & dosage ; ARTICLES AND COMMENTARIES ; Biological and medical sciences ; Blood ; Bones, joints and connective tissue. Antiinflammatory agents ; Chile ; Clinical trials ; Double-Blind Method ; Drug dosages ; Female ; Hantavirus ; Hantavirus pulmonary syndrome ; Hantavirus Pulmonary Syndrome - drug therapy ; Hantavirus Pulmonary Syndrome - mortality ; Hemorrhagic fever with renal syndrome ; Humans ; Immunoglobulins ; Infectious diseases ; Kaplan-Meier Estimate ; Lung diseases ; Male ; Medical sciences ; Methylprednisolone - administration & dosage ; Middle Aged ; Orthohantavirus - genetics ; Orthohantavirus - isolation & purification ; Pharmacology. Drug treatments ; Placebo effect ; Placebos ; Registered nurses ; Ribonucleic acid ; RNA ; RNA, Viral - blood ; Sofas ; Treatment Outcome ; Viral infections ; Viral load
Is Part Of: Clinical infectious diseases, 2013-10, Vol.57 (7), p.943-951
Notes: ObjectType-Article-1
SourceType-Scholarly Journals-1
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Description: 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. Clinical Trials Registration. NCT00128180.
Publisher: Oxford: Oxford University Press
Language: English

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

Vial, Pablo A. ; Valdivieso, Francisca ; Ferres, Marcela ; Riquelme, Raul ; Rioseco, M. Luisa ; Calvo, Mario ; Castillo, Constanza ; Díaz, Ricardo ; Scholz, Luis ; Cuiza, Analia ; Belmar, Edith ; Hernandez, Carla ; Martinez, Jessica ; Lee, Sang-Joon ; Mertz, Gregory J.

Oxford: Oxford University Press

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