Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/104361
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Villarino, M.Elsa | - |
dc.contributor.author | Scott, Nigel A. | - |
dc.contributor.author | Weis, Stephen E. | - |
dc.contributor.author | Weiner, Marc | - |
dc.contributor.author | Conde, Marcus B. | - |
dc.contributor.author | Jones, Brenda | - |
dc.contributor.author | Nachman, Sharon | - |
dc.contributor.author | Oliveira, Ricardo | - |
dc.contributor.author | Moro, Ruth N. | - |
dc.contributor.author | Shang, Nong | - |
dc.contributor.author | Goldberg, Stefan V. | - |
dc.contributor.author | Sterling, Timothy R. | - |
dc.contributor.author | Miró Meda, José M. | - |
dc.contributor.author | IMPAACT Group | - |
dc.date.accessioned | 2016-12-01T16:48:49Z | - |
dc.date.available | 2016-12-01T16:48:49Z | - |
dc.date.issued | 2015-01-12 | - |
dc.identifier.issn | 2168-6203 | - |
dc.identifier.uri | http://hdl.handle.net/2445/104361 | - |
dc.description.abstract | IMPORTANCE: 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.extent | 9 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Medical Association | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1001/jamapediatrics.2014.3158 | - |
dc.relation.ispartof | JAMA Pediatrics, 2015, vol. 169, num. 3, p. 247-255 | - |
dc.relation.uri | https://doi.org/10.1001/jamapediatrics.2014.3158 | - |
dc.rights | (c) American Medical Association, 2015 | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Tuberculosi | - |
dc.subject.classification | Infants | - |
dc.subject.classification | Adolescents | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.other | Tuberculosis | - |
dc.subject.other | Children | - |
dc.subject.other | Teenagers | - |
dc.subject.other | Clinical trials | - |
dc.title | Treatment 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.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 660842 | - |
dc.date.updated | 2016-12-01T16:48:54Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 25580725 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
660842.pdf | 342.56 kB | Adobe PDF | View/Open | |
supp1_authorslist.pdf | 137.82 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.