Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/104361
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dc.contributor.authorVillarino, M.Elsa-
dc.contributor.authorScott, Nigel A.-
dc.contributor.authorWeis, Stephen E.-
dc.contributor.authorWeiner, Marc-
dc.contributor.authorConde, Marcus B.-
dc.contributor.authorJones, Brenda-
dc.contributor.authorNachman, Sharon-
dc.contributor.authorOliveira, Ricardo-
dc.contributor.authorMoro, Ruth N.-
dc.contributor.authorShang, Nong-
dc.contributor.authorGoldberg, Stefan V.-
dc.contributor.authorSterling, Timothy R.-
dc.contributor.authorMiró Meda, José M.-
dc.contributor.authorIMPAACT Group-
dc.date.accessioned2016-12-01T16:48:49Z-
dc.date.available2016-12-01T16:48:49Z-
dc.date.issued2015-01-12-
dc.identifier.issn2168-6203-
dc.identifier.urihttp://hdl.handle.net/2445/104361-
dc.description.abstractIMPORTANCE: Three months of a once-weekly combination of rifapentine and isoniazid for treatment of latent tuberculosis infection is safe and effective for persons 12 years or older. Published data for children are limited. OBJECTIVES: To compare treatment safety and assess noninferiority treatment effectiveness of combination therapy with rifapentine and isoniazid vs 9 months of isoniazid treatment for latent tuberculosis infection in children. DESIGN, SETTING, AND PARTICIPANTS: A pediatric cohort nested within a randomized, open-label clinical trial conducted from June 11, 2001, through December 17, 2010, with follow-up through September 5, 2013, in 29 study sites in the United States, Canada, Brazil, Hong Kong (China), and Spain. Participants were children (aged 2-17 years) who were eligible for treatment of latent tuberculosis infection. INTERVENTIONS: Twelve once-weekly doses of the combination drugs, given with supervision by a health care professional, for 3 months vs 270 daily doses of isoniazid, without supervision by a health care professional, for 9 months. MAIN OUTCOMES AND MEASURES: We compared rates of treatment discontinuation because of adverse events (AEs), toxicity grades 1 to 4, and deaths from any cause. The equivalence margin for the comparison of AE-related discontinuation rates was 5%. Tuberculosis disease diagnosed within 33 months of enrollment was the main end point for testing effectiveness. The noninferiority margin was 0.75%. RESULTS: Of 1058 children enrolled, 905 were eligible for evaluation of effectiveness. Of 471 in the combination-therapy group, 415 (88.1%) completed treatment vs 351 of 434 (80.9%) in the isoniazid-only group (P = .003). The 95% CI for the difference in rates of discontinuation attributed to an AE was -2.6 to 0.1, which was within the equivalence range. In the safety population, 3 of 539 participants (0.6%) who took the combination drugs had a grade 3 AE vs 1 of 493 (0.2%) who received isoniazid only. Neither arm had any hepatotoxicity, grade 4 AEs, or treatment-attributed death. None of the 471 in the combination-therapy group developed tuberculosis vs 3 of 434 (cumulative rate, 0.74%) in the isoniazid-only group, for a difference of -0.74% and an upper bound of the 95% CI of the difference of +0.32%, which met the noninferiority criterion. CONCLUSIONS AND RELEVANCE: Treatment with the combination of rifapentine and isoniazid was as effective as isoniazid-only treatment for the prevention of tuberculosis in children aged 2 to 17 years. The combination-therapy group had a higher treatment completion rate than did the isoniazid-only group and was safe.-
dc.format.extent9 p.-
dc.format.mimetypeapplication/pdf-
dc.language.isoeng-
dc.publisherAmerican Medical Association-
dc.relation.isformatofReproducció del document publicat a: https://doi.org/10.1001/jamapediatrics.2014.3158-
dc.relation.ispartofJAMA Pediatrics, 2015, vol. 169, num. 3, p. 247-255-
dc.relation.urihttps://doi.org/10.1001/jamapediatrics.2014.3158-
dc.rights(c) American Medical Association, 2015-
dc.sourceArticles publicats en revistes (Medicina)-
dc.subject.classificationTuberculosi-
dc.subject.classificationInfants-
dc.subject.classificationAdolescents-
dc.subject.classificationAssaigs clínics-
dc.subject.otherTuberculosis-
dc.subject.otherChildren-
dc.subject.otherTeenagers-
dc.subject.otherClinical trials-
dc.titleTreatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid-
dc.typeinfo:eu-repo/semantics/article-
dc.typeinfo:eu-repo/semantics/publishedVersion-
dc.identifier.idgrec660842-
dc.date.updated2016-12-01T16:48:54Z-
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess-
dc.identifier.pmid25580725-
Appears in Collections:Articles publicats en revistes (Medicina)

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