Evidence map›Paper›PMID 23784924›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2013

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

Pablo A Vial, Francisca Valdivieso, Marcela Ferres, Raul Riquelme, M Luisa Rioseco, Mario Calvo, Constanza Castillo, Ricardo Díaz, Luis Scholz, Analia Cuiza and 6 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00128180 (A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00128180 phase2completednot on this map

A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome

TypeinterventionalSponsorUniversity of New MexicoRan2003 to 2011Enrolled66ConditionsHantavirus InfectionsArmsMethylprednisolone, Placebo
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.

  1. Pooled it
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  16. Emerging Maripa Hantavirus as a Potential Cause of a Severe Health Threat in French Guiana.The American journal of tropical medicine and hygiene · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Pablo A VialFacultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago.
Francisca Valdivieso
Marcela Ferres
Raul Riquelme
M Luisa Rioseco
Mario Calvo
Constanza Castillo
Ricardo Díaz
Luis Scholz
Analia Cuiza
Edith Belmar
Carla Hernandez
Jessica Martinez
Sang-Joon Lee
Gregory J Mertz
Hantavirus Study Group in Chile
Universidad del Desarrollo · CLHospital Base · CLClínica Alemana · CLUniversidad de La Frontera · CLUniversity of New Mexico · USAustral University of Chile · CL

Funding

Virology/Immunology CoreU19AI045452 · NIAID · UNIVERSITY OF NEW MEXICO · PI MERTZ, GREGORY JAMES · 1999 to 2009
$8.7M
NIAID NIH HHS 5U19AI045452NIAID NIH HHS U19 AI045452
6 · The paper itself

Abstract

backgroundAndes 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.

methodsPatients 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.

resultsInfection 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.

conclusionsAlthough 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.

Indexed as

Administration, IntravenousAdolescentAdultAnti-Inflammatory AgentsChileDouble-Blind MethodFemaleHantavirus Pulmonary SyndromeHumansKaplan-Meier EstimateMaleMethylprednisoloneMiddle AgedOrthohantavirusRNA, ViralTreatment OutcomeAnti-Inflammatory AgentsMethylprednisoloneRNA, Viralclinical trialhantavirushantavirus cardiopulmonary syndromehantavirus pulmonary syndromemethylprednisolone

Identifiers

PMID23784924
PMCPMC3765009
OpenAlexW2099325304

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.