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High-dose intravenous methylprednisolone for hantavirus cardiopulmonary syndrome in Chile: a double-blind, randomized controlled clinical trial

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dc.contributor.author Vial, Pablo
dc.contributor.author Valdivieso, Francisca
dc.contributor.author Ferres, Marcela
dc.contributor.author Riquelme, Raul
dc.contributor.author Rioseco, Maria
dc.contributor.author Calvo, Mario
dc.contributor.author Castillo, Constanza
dc.contributor.author Diaz, Ricardo
dc.contributor.author Scholz, Luis
dc.contributor.author Cuiza, Analia
dc.contributor.author Belmar, Edith
dc.contributor.author Hernandez, Carla
dc.contributor.author Martinez, Jessica
dc.contributor.author Lee, Sang-Joon
dc.contributor.author Mertz, Gregory
dc.date.accessioned 2017-04-18T15:00:23Z
dc.date.available 2017-04-18T15:00:23Z
dc.date.issued 2013
dc.identifier.citation Clin Infect Dis. 2013 Oct;57(7):943-951 es_CL
dc.identifier.uri http://dx.doi.org/10.1093/cid/cit394 es_CL
dc.identifier.uri http://hdl.handle.net/11447/1171
dc.description.abstract 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. es_CL
dc.format.extent 9 es_CL
dc.language.iso en_US es_CL
dc.publisher Oxford University Press es_CL
dc.subject hantavirus es_CL
dc.subject hantavirus cardiopulmonary syndrome es_CL
dc.subject hantavirus pulmonary syndrome es_CL
dc.subject methylprednisolone es_CL
dc.subject clinical trial es_CL
dc.title High-dose intravenous methylprednisolone for hantavirus cardiopulmonary syndrome in Chile: a double-blind, randomized controlled clinical trial es_CL
dc.type Artículo es_CL


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