Título:
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Single-Dose Tafenoquine to Prevent Relapse of Plasmodium vivax Malaria
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Autores:
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Lacerda, Marcus V. G. ;
Llanos-Cuentas, Alejandro ;
Krudsood, Srivicha ;
Lon, Chanthap ;
Saunders, David L. ;
Mohammed, Rezika ;
Yilma, Daniel ;
Batista Pereira, Dhelio ;
Espino, Fe E. J. ;
Mia, Reginaldo Z. ;
Chuquiyauri, Raúl ;
Val, Fernando ;
Casapía, Martin ;
Monteiro, Wuelton M. ;
Brito, Marcelo A. M. ;
Costa, Monica R. F. ;
Buathong, Nillawan ;
Noedl, Harald ;
Diro, Ermias ;
Getie, Sisay ;
Wubie, Kalehiwot M. ;
Abdissa, Alemseged ;
Zeynudin, Ahmed ;
Abebe, Cherinet ;
Tada, Mauro S. ;
Brand, Francoise ;
Beck, Hans-Peter ;
Angus, Brian ;
Duparc, Stephan ;
Kleim, Jorg-Peter ;
Kellam, Lynda M. ;
Rousell, Victoria M. ;
Jones, Sion W. ;
Hardaker, Elizabeth ;
Mohamed, Khadeeja ;
Clover, Donna D. ;
Fletcher, Kim ;
Breton, John J. ;
Ugwuegbulam, Cletus O. ;
Green, Justin A. ;
Koh, Gavin C. K. W.
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Tipo de documento:
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texto impreso
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Editorial:
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Massachusetts Medical Society, 2019-07-04T17:00:24Z
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Nota general:
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info:eu-repo/semantics/restrictedAccess
https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
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Idiomas:
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Inglés
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Palabras clave:
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Editados por otras instituciones
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Artículos en revistas indizadas
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Resumen:
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BACKGROUND: Treatment of Plasmodium vivax malaria requires the clearing of asexual parasites, but relapse can be prevented only if dormant hypnozoites are cleared from the liver (a treatment termed "radical cure"). Tafenoquine is a single-dose 8-aminoquinoline that has recently been registered for the radical cure of P. vivax. METHODS: This multicenter, double-blind, double-dummy, parallel group, randomized, placebo-controlled trial was conducted in Ethiopia, Peru, Brazil, Cambodia, Thailand, and the Philippines. We enrolled 522 patients with microscopically confirmed P. vivax infection (>100 to /=70% of the median value determined at each trial site among 36 healthy male volunteers who were otherwise not involved in the trial). All patients received a 3-day course of chloroquine (total dose of 1500 mg). In addition, patients were assigned to receive a single 300-mg dose of tafenoquine on day 1 or 2 (260 patients), placebo (133 patients), or a 15-mg dose of primaquine once daily for 14 days (129 patients). The primary outcome was the Kaplan-Meier estimated percentage of patients who were free from recurrence at 6 months, defined as P. vivax clearance without recurrent parasitemia. RESULTS: In the intention-to-treat population, the percentage of patients who were free from recurrence at 6 months was 62.4% in the tafenoquine group (95% confidence interval [CI], 54.9 to 69.0), 27.7% in the placebo group (95% CI, 19.6 to 36.6), and 69.6% in the primaquine group (95% CI, 60.2 to 77.1). The hazard ratio for the risk of recurrence was 0.30 (95% CI, 0.22 to 0.40) with tafenoquine as compared with placebo (P
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En línea:
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http://doi.org/10.1056/NEJMoa1710775
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