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

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dc.contributor.authorVial, Pablo
dc.contributor.authorValdivieso, Francisca
dc.contributor.authorFerres, Marcela
dc.contributor.authorRiquelme, Raul
dc.contributor.authorRioseco, Maria
dc.contributor.authorCalvo, Mario
dc.contributor.authorCastillo, Constanza
dc.contributor.authorDiaz, Ricardo
dc.contributor.authorScholz, Luis
dc.contributor.authorCuiza, Analía
dc.contributor.authorBelmar, Edith
dc.contributor.authorHernandez, Carla
dc.contributor.authorMartinez, Jessica
dc.contributor.authorLee, Sang-Joon
dc.contributor.authorMertz, Gregory
dc.date.accessioned2017-04-18T15:00:23Z
dc.date.available2017-04-18T15:00:23Z
dc.date.issued2013
dc.description.abstractBACKGROUND: 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.
dc.format.extent9
dc.identifier.citationClinical Infectious Diseases, 2013, 57(7):943-951
dc.identifier.urihttp://hdl.handle.net/11447/1171
dc.identifier.urihttp://dx.doi.org/10.1093/cid/cit394
dc.language.isoen_US
dc.publisherOxford University Press
dc.subjecthantavirus
dc.subjecthantavirus cardiopulmonary syndrome
dc.subjecthantavirus pulmonary syndrome
dc.subjectmethylprednisolone
dc.subjectclinical trial
dc.titleHigh-dose intravenous methylprednisolone for hantavirus cardiopulmonary syndrome in Chile: a double-blind, randomized controlled clinical trial
dc.typeArtículo

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