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[Background and purpose] Screening for and treatment of latent tuberculosis (TB) in patients with end-stage kidney disease (ESKD) are recommended. However, there is limited evidence on safety and treatment completion in this population. The objective of the study is to evaluate three short-course rifamycin-based regimens for the treatment of latent TB in ESKD patients., [Methods] Study design and setting. This is a prospective, open label, randomized clinical trial, that will be conducted at seven teaching hospitals in Spain. Study population, randomization, and interventions. Consecutive adult patients with ESKD requiring treatment for a latent TB infection will be randomly allocated (1:1:1) to receive one of the three treatment regimens of the study: three months of daily isoniazid plus rifampicin (3HR); three months of once-weekly isoniazid plus rifapentine (3HP); or four months of daily rifampicin (4R). Participants will be followed regularly through pre-established visits and a blood test schedule from enrolment to a month after finishing the assigned treatment. Outcomes. The primary outcome will be treatment completion, while the secondary outcomes will be discontinuation of the assigned treatment due to adverse events, related or unrelated to the study treatment; definitive discontinuation of the assigned treatment because of adverse events related to the treatment of the study, and death. Sample size. Two hundred and twenty-five subjects (75 per arm) will be enrolled, which will enable the demonstration, if it exists, of an increase of 0.16 in treatment completion rates either in the 3HP or 4R arm with respect to the 3HR arm., [Discussion] Results of this clinical trial will contribute to evidence-based recommendations on the management of latent TB infection in ESKD patients., [Trial registration] ClinicalTrials.gov identifier: NCT05021731., This study is funded by the Instituto de Salud Carlos III through the grant “21/004444” (co-funded by the European Regional Development Fund/European Social Fund, “Investing in Your Future”).

Grupo de Trabajo del Programa Integrado de Investigación en Tuberculosis (PII-TB). In Press., [EN]: [Objective] The objective of the study was to determine the trend of variables related to tuberculosis (TB) from the Integrated Tuberculosis Research Program (PII-TB) registry of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), and to evaluate the PII-TB according to indicators related to its scientific objectives. [Method] Cross-sectional, population-based, multicenter study of new TB cases prospectively registered in the PII-TB between 2006 and 2016. The time trend of quantitative variables was calculated using a lineal regression model, and qualitative variables using the χy test for lineal trend. [Results] A total of 6,892 cases with an annual median of 531 were analyzed. Overall, a significant downward trend was observed in women, immigrants, prisoners, and patients initially treated with 3 drugs. Significant upward trends were observed in patients aged 40-50 and > 50 years, first visit conducted by a specialist, hospitalization, diagnostic delay, disseminated disease and single extrapulmonary location, culture(+), sensitivity testing performed, drug resistance, directly observed treatment, prolonged treatment, and death from another cause. The scientific objectives of the PII-TB that showed a significant upward trend were publications, which reached a maximum of 8 in 2016 with a total impact factor of 49,664, numbers of projects initiated annually, presentations at conferences, and theses. [Conclusions] PII-TB provides relevant information on TB and its associated factors in Spain. A large team of researchers has been created; some scientific aspects of the registry were positive, while others could have been improved., [ES]: [Objetivo] El objetivo del estudio fue conocer la tendencia de las variables relacionadas con la tuberculosis (TB) en España a partir del registro del Programa Integrado de Investigación en Tuberculosis (PII-TB) de la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) y evaluar el PII-TB mediante indicadores relacionados con sus objetivos científicos. [Método] Estudio transversal multicéntrico de base poblacional de casos nuevos de TB registrados prospectivamente por el PII-TB entre 2006 y 2016. La tendencia temporal de variables cuantitativas se realizó mediante un modelo de regresión lineal y las cualitativas mediante la prueba de χ2 de tendencia lineal. [Resultados] Se analizaron 6.892 casos de TB con una mediana anual de 531. La tendencia general fue significativamente decreciente en mujeres, inmigrantes, privados de libertad y en tratados inicialmente con 3fármacos. Se incrementaron significativamente la tendencia de grupos de 40 -50 años y > 50 años, primera atención por especialista de zona, hospitalización, retraso diagnóstico, localización diseminada y extrapulmonar única, cultivo (+), realización de antibiogramas, resistencia a fármacos, tratamiento directamente observado, prolongación del tratamiento y muerte por otra causa. Los objetivos científicos del PII-TB que incrementaron significativamente fueron las publicaciones alcanzando un máximo de 8 en 2016 y con un factor de impacto total de 49,664, y también mejoraron los proyectos iniciados anualmente, presentaciones en congresos y las tesis o tesinas. [Conclusiones] El PII-TB proporciona información relevante sobre la TB y sus factores asociados en España. Se ha formado un amplio equipo de investigadores y se han detectado aspectos científicos positivos y otros mejorables.