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dc.contributor.authorTorre Cisneros, Julián
dc.contributor.authorSan Juan, Rafael
dc.contributor.authorRosso Fernández, Clara
dc.contributor.authorTiago Silva, J
dc.contributor.authorMuñoz Sanz, Agustín
dc.contributor.authorMuñoz, Patricia
dc.contributor.authorMiguez, Enrique
dc.contributor.authorMartín-Dávila, Pilar
dc.contributor.authorLópez Ruz, Miguel Ángel 
dc.contributor.authorVidal, Elisa
dc.contributor.authorCordero, Elisa
dc.contributor.authorMontejo, Miguel
dc.contributor.authorBlanes, Marino
dc.contributor.authorFariñas, Carmen
dc.contributor.authorHerrero, José Ignacio
dc.contributor.authorRodrigo, Juan
dc.contributor.authorAguado, Jose María
dc.date.accessioned2024-04-22T07:40:33Z
dc.date.available2024-04-22T07:40:33Z
dc.date.issued2015-02-25
dc.identifier.citationTorre-Cisneros, J. et al. Tuberculosis Prophylaxis With Levofloxacin in Liver Transplant Patients Is Associated With a High Incidence of Tenosynovitis: Safety Analysis of a Multicenter Randomized Trial, Clinical Infectious Diseases, Volume 60, Issue 11, 1 June 2015, Pages 1642–1649, https://doi.org/10.1093/cid/civ156es_ES
dc.identifier.urihttps://hdl.handle.net/10481/90982
dc.descriptionThis work was supported by the Ayudas para el fomento de la investigacion clinica independiente [EC 10-120] and Programa Intramural Consorcio de Apoyo a la Investigación Biomédica en Red 2010. Other funding sources: National R&D&I Plan 2008–2011 and the Instituto de Salud Carlos III (ISCIII), Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía y Competitividad, Spanish Network for Research in Infectious Diseases [RD06/0008, RD12/0015] - co-financed by European Development Regional Fund “A way to achieve Europe” ERDF. Consorcio de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas is financed by the ISCIII.es_ES
dc.description.abstractBackground: It is necessary to develop a safe alternative to isoniazid for tuberculosis prophylaxis in liver transplant recipients. This study was designed to investigate the efficacy and safety of levofloxacin. Methods: An open-label, prospective, multicenter, randomized study was conducted to compare the efficacy and safety of levofloxacin (500 mg q24h for 9 months) initiated in patients awaiting liver transplantation and isoniazid (300 mg q24h for 9 months) initiated post-transplant when liver function was stabilized. Efficacy was measured by tuberculosis incidence at 18 months after transplantation. All adverse events related to the medication were recorded. Results: CONSORT guidelines were followed in order to present the results. The safety committee suspended the study through a safety analysis when 64 patients had been included (31 in the isoniazid arm and 33 in the levofloxacin arm). The reason for suspension was an unexpected incidence of severe tenosynovitis in the levofloxacin arm (18.2%). Although the clinical course was favorable in all cases, tenosynovitis persisted for 7 weeks in some patients. No patients treated with isoniazid, developed tenosynovitis. Only 32.2% of patients randomized to isoniazid (10/31) and 54.5% of patients randomized to levofloxacin (18/33, P = .094) completed prophylaxis. No patient developed tuberculosis during the study follow-up (median 270 days). Conclusions: Levofloxacin prophylaxis of tuberculosis in liver transplant candidates is associated with a high incidence of tenosynovitis that limits its potential utility.es_ES
dc.description.sponsorshipAyudas para el fomento de la investigación clínica independiente [EC 10-120]es_ES
dc.description.sponsorshipPrograma Intramural Consorcio de Apoyo a la Investigación Biomédica en Red 2010es_ES
dc.description.sponsorshipNational R&D&I Plan 2008–2011es_ES
dc.description.sponsorshipInstituto de Salud Carlos III (ISCIII)es_ES
dc.description.sponsorshipMinisterio de Economía y Competitividad RD06/0008, RD12/0015es_ES
dc.description.sponsorshipEuropean Development Regional Fundes_ES
dc.language.isoenges_ES
dc.publisherOxford University Presses_ES
dc.rightsCreative Commons Attribution-NonCommercial-NoDerivs 3.0 Licensees_ES
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/es_ES
dc.subjectTuberculosis es_ES
dc.subjectLevofloxacines_ES
dc.subjectTenosynovitises_ES
dc.subjectInvestigator-driven clinical triales_ES
dc.titleTuberculosis prophylaxis with levofloxacin in liver transplant patients is associated with a high incidence of tenosynovitis: safety analysis of a multicenter randomized triales_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses_ES
dc.identifier.doi10.1093/cid/civ156
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones_ES


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