Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study

The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to...

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Main Authors: Akkerman, Onno, Aleksa, Alena, Alffenaar, Jan Willem, Al-Marzouqi, Nada Hassan, Arias Guillén, Miguel, Belilovski, Evgeny, Bernal, Enrique, Boeree, Martin J., Borisov, Sergey, Bruchfeld, Judith, Cadiñanos Loidi, Julen, Cai, Qingshan, Caminero, Jose A., Cebrian Gallardo, Jose Joaquín, Centis, Rosella, Codecasa, Luigi Ruffo, D’Ambrosio, Lia, Dalcolmo, Margareth Pretti, Danila, Edvardas, Dara, Masoud, Davidavičienė, Edita, Davies Forsman, Lina, De Los Rios Jefe, Jorge, Denholm, Justin, Duarte, Raquel, Elamin, Seifeldin Eltaeb, Ferrarese, Maurizio, Filippov, Alexey, Ganatra, Shashank, Garcia, Ana, García García, José María, Gayoso, Regina, Giraldo Montoya, Angela Maria, Gómez Rosso, Roscio Gómez, Gualano, Gina, Hoefsloot, Wouter, Ilievska Poposka, Biljana, Jonsson, Jerker, Khimova, Elena, Kuksa, Liga, Kunst, Heinke, Laniado Laborín, Rafael, Li, Yang, Magis Escurra, Cecile, Manfrin, Vinicio, Manga, Selene, Marchese, Valentina, Martínez Robles, Elena, Maryandyshev, Andrei, Matteelli, Alberto, Migliori, Giovanni Battista, Mullerpattan, Jai B., Muñoz Torrico, Marcela, Mustafa Hamdan, Hamdan, Nieto Marcos, Magnolia, Noordin, Noorliza Mohamad, Palmero, Domingo Juan, Palmieri, Fabrizio, Payen, Marie Christine, Piubello, Alberto, Pontali, Emanuele, Pontarelli, Agostina, Quirós, Sarai, Rendón, Adrián, Skrahina, Alena, Smite, Agnese, Solovic, Ivan, Sotgiu, Giovanni, Souleymane, Mahamadou Bassirou, Spanevello, Antonio, Stošić, Maja, Tadolini, Marina, Tiberi, Simon, Udwadia, Zarir Farokh, Van den Boom, Martin, Vescovo, Marisa, Viggiani, Pietro, Visca, Dina, Zhurkin, Dmitry, Zignol, Matteo
Format: Article
Language:English
Published: Elsevier Science 2019
Subjects:
Online Access:http://eprints.uanl.mx/23472/1/23472.pdf
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author Akkerman, Onno
Aleksa, Alena
Alffenaar, Jan Willem
Al-Marzouqi, Nada Hassan
Arias Guillén, Miguel
Belilovski, Evgeny
Bernal, Enrique
Boeree, Martin J.
Borisov, Sergey
Bruchfeld, Judith
Cadiñanos Loidi, Julen
Cai, Qingshan
Caminero, Jose A.
Cebrian Gallardo, Jose Joaquín
Centis, Rosella
Codecasa, Luigi Ruffo
D’Ambrosio, Lia
Dalcolmo, Margareth Pretti
Danila, Edvardas
Dara, Masoud
Davidavičienė, Edita
Davies Forsman, Lina
De Los Rios Jefe, Jorge
Denholm, Justin
Duarte, Raquel
Elamin, Seifeldin Eltaeb
Ferrarese, Maurizio
Filippov, Alexey
Ganatra, Shashank
Garcia, Ana
García García, José María
Gayoso, Regina
Giraldo Montoya, Angela Maria
Gómez Rosso, Roscio Gómez
Gualano, Gina
Hoefsloot, Wouter
Ilievska Poposka, Biljana
Jonsson, Jerker
Khimova, Elena
Kuksa, Liga
Kunst, Heinke
Laniado Laborín, Rafael
Li, Yang
Magis Escurra, Cecile
Manfrin, Vinicio
Manga, Selene
Marchese, Valentina
Martínez Robles, Elena
Maryandyshev, Andrei
Matteelli, Alberto
Migliori, Giovanni Battista
Mullerpattan, Jai B.
Muñoz Torrico, Marcela
Mustafa Hamdan, Hamdan
Nieto Marcos, Magnolia
Noordin, Noorliza Mohamad
Palmero, Domingo Juan
Palmieri, Fabrizio
Payen, Marie Christine
Piubello, Alberto
Pontali, Emanuele
Pontarelli, Agostina
Quirós, Sarai
Rendón, Adrián
Skrahina, Alena
Smite, Agnese
Solovic, Ivan
Sotgiu, Giovanni
Souleymane, Mahamadou Bassirou
Spanevello, Antonio
Stošić, Maja
Tadolini, Marina
Tiberi, Simon
Udwadia, Zarir Farokh
Van den Boom, Martin
Vescovo, Marisa
Viggiani, Pietro
Visca, Dina
Zhurkin, Dmitry
Zignol, Matteo
author_facet Akkerman, Onno
Aleksa, Alena
Alffenaar, Jan Willem
Al-Marzouqi, Nada Hassan
Arias Guillén, Miguel
Belilovski, Evgeny
Bernal, Enrique
Boeree, Martin J.
Borisov, Sergey
Bruchfeld, Judith
Cadiñanos Loidi, Julen
Cai, Qingshan
Caminero, Jose A.
Cebrian Gallardo, Jose Joaquín
Centis, Rosella
Codecasa, Luigi Ruffo
D’Ambrosio, Lia
Dalcolmo, Margareth Pretti
Danila, Edvardas
Dara, Masoud
Davidavičienė, Edita
Davies Forsman, Lina
De Los Rios Jefe, Jorge
Denholm, Justin
Duarte, Raquel
Elamin, Seifeldin Eltaeb
Ferrarese, Maurizio
Filippov, Alexey
Ganatra, Shashank
Garcia, Ana
García García, José María
Gayoso, Regina
Giraldo Montoya, Angela Maria
Gómez Rosso, Roscio Gómez
Gualano, Gina
Hoefsloot, Wouter
Ilievska Poposka, Biljana
Jonsson, Jerker
Khimova, Elena
Kuksa, Liga
Kunst, Heinke
Laniado Laborín, Rafael
Li, Yang
Magis Escurra, Cecile
Manfrin, Vinicio
Manga, Selene
Marchese, Valentina
Martínez Robles, Elena
Maryandyshev, Andrei
Matteelli, Alberto
Migliori, Giovanni Battista
Mullerpattan, Jai B.
Muñoz Torrico, Marcela
Mustafa Hamdan, Hamdan
Nieto Marcos, Magnolia
Noordin, Noorliza Mohamad
Palmero, Domingo Juan
Palmieri, Fabrizio
Payen, Marie Christine
Piubello, Alberto
Pontali, Emanuele
Pontarelli, Agostina
Quirós, Sarai
Rendón, Adrián
Skrahina, Alena
Smite, Agnese
Solovic, Ivan
Sotgiu, Giovanni
Souleymane, Mahamadou Bassirou
Spanevello, Antonio
Stošić, Maja
Tadolini, Marina
Tiberi, Simon
Udwadia, Zarir Farokh
Van den Boom, Martin
Vescovo, Marisa
Viggiani, Pietro
Visca, Dina
Zhurkin, Dmitry
Zignol, Matteo
author_sort Akkerman, Onno
collection Repositorio Institucional
description The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries.The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs.Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile.A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019. Keywords: Tuberculosis, MDR-TB, Adverse events, Monitoring, Delamanid, Bedaquiline
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spelling eprints-234722024-12-10T20:07:47Z http://eprints.uanl.mx/23472/ Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study Akkerman, Onno Aleksa, Alena Alffenaar, Jan Willem Al-Marzouqi, Nada Hassan Arias Guillén, Miguel Belilovski, Evgeny Bernal, Enrique Boeree, Martin J. Borisov, Sergey Bruchfeld, Judith Cadiñanos Loidi, Julen Cai, Qingshan Caminero, Jose A. Cebrian Gallardo, Jose Joaquín Centis, Rosella Codecasa, Luigi Ruffo D’Ambrosio, Lia Dalcolmo, Margareth Pretti Danila, Edvardas Dara, Masoud Davidavičienė, Edita Davies Forsman, Lina De Los Rios Jefe, Jorge Denholm, Justin Duarte, Raquel Elamin, Seifeldin Eltaeb Ferrarese, Maurizio Filippov, Alexey Ganatra, Shashank Garcia, Ana García García, José María Gayoso, Regina Giraldo Montoya, Angela Maria Gómez Rosso, Roscio Gómez Gualano, Gina Hoefsloot, Wouter Ilievska Poposka, Biljana Jonsson, Jerker Khimova, Elena Kuksa, Liga Kunst, Heinke Laniado Laborín, Rafael Li, Yang Magis Escurra, Cecile Manfrin, Vinicio Manga, Selene Marchese, Valentina Martínez Robles, Elena Maryandyshev, Andrei Matteelli, Alberto Migliori, Giovanni Battista Mullerpattan, Jai B. Muñoz Torrico, Marcela Mustafa Hamdan, Hamdan Nieto Marcos, Magnolia Noordin, Noorliza Mohamad Palmero, Domingo Juan Palmieri, Fabrizio Payen, Marie Christine Piubello, Alberto Pontali, Emanuele Pontarelli, Agostina Quirós, Sarai Rendón, Adrián Skrahina, Alena Smite, Agnese Solovic, Ivan Sotgiu, Giovanni Souleymane, Mahamadou Bassirou Spanevello, Antonio Stošić, Maja Tadolini, Marina Tiberi, Simon Udwadia, Zarir Farokh Van den Boom, Martin Vescovo, Marisa Viggiani, Pietro Visca, Dina Zhurkin, Dmitry Zignol, Matteo RA Aspectos Públicos de la Medicina The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries.The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs.Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile.A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019. Keywords: Tuberculosis, MDR-TB, Adverse events, Monitoring, Delamanid, Bedaquiline Elsevier Science 2019 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/23472/1/23472.pdf http://eprints.uanl.mx/23472/1.haspreviewThumbnailVersion/23472.pdf Akkerman, Onno y Aleksa, Alena y Alffenaar, Jan Willem y Al-Marzouqi, Nada Hassan y Arias Guillén, Miguel y Belilovski, Evgeny y Bernal, Enrique y Boeree, Martin J. y Borisov, Sergey y Bruchfeld, Judith y Cadiñanos Loidi, Julen y Cai, Qingshan y Caminero, Jose A. y Cebrian Gallardo, Jose Joaquín y Centis, Rosella y Codecasa, Luigi Ruffo y D’Ambrosio, Lia y Dalcolmo, Margareth Pretti y Danila, Edvardas y Dara, Masoud y Davidavičienė, Edita y Davies Forsman, Lina y De Los Rios Jefe, Jorge y Denholm, Justin y Duarte, Raquel y Elamin, Seifeldin Eltaeb y Ferrarese, Maurizio y Filippov, Alexey y Ganatra, Shashank y Garcia, Ana y García García, José María y Gayoso, Regina y Giraldo Montoya, Angela Maria y Gómez Rosso, Roscio Gómez y Gualano, Gina y Hoefsloot, Wouter y Ilievska Poposka, Biljana y Jonsson, Jerker y Khimova, Elena y Kuksa, Liga y Kunst, Heinke y Laniado Laborín, Rafael y Li, Yang y Magis Escurra, Cecile y Manfrin, Vinicio y Manga, Selene y Marchese, Valentina y Martínez Robles, Elena y Maryandyshev, Andrei y Matteelli, Alberto y Migliori, Giovanni Battista y Mullerpattan, Jai B. y Muñoz Torrico, Marcela y Mustafa Hamdan, Hamdan y Nieto Marcos, Magnolia y Noordin, Noorliza Mohamad y Palmero, Domingo Juan y Palmieri, Fabrizio y Payen, Marie Christine y Piubello, Alberto y Pontali, Emanuele y Pontarelli, Agostina y Quirós, Sarai y Rendón, Adrián y Skrahina, Alena y Smite, Agnese y Solovic, Ivan y Sotgiu, Giovanni y Souleymane, Mahamadou Bassirou y Spanevello, Antonio y Stošić, Maja y Tadolini, Marina y Tiberi, Simon y Udwadia, Zarir Farokh y Van den Boom, Martin y Vescovo, Marisa y Viggiani, Pietro y Visca, Dina y Zhurkin, Dmitry y Zignol, Matteo (2019) Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study. International Journal of Infectious Diseases, 83. pp. 72-76. ISSN 12019712 http://doi.org/10.1016/j.ijid.2019.03.036 doi:10.1016/j.ijid.2019.03.036
spellingShingle RA Aspectos Públicos de la Medicina
Akkerman, Onno
Aleksa, Alena
Alffenaar, Jan Willem
Al-Marzouqi, Nada Hassan
Arias Guillén, Miguel
Belilovski, Evgeny
Bernal, Enrique
Boeree, Martin J.
Borisov, Sergey
Bruchfeld, Judith
Cadiñanos Loidi, Julen
Cai, Qingshan
Caminero, Jose A.
Cebrian Gallardo, Jose Joaquín
Centis, Rosella
Codecasa, Luigi Ruffo
D’Ambrosio, Lia
Dalcolmo, Margareth Pretti
Danila, Edvardas
Dara, Masoud
Davidavičienė, Edita
Davies Forsman, Lina
De Los Rios Jefe, Jorge
Denholm, Justin
Duarte, Raquel
Elamin, Seifeldin Eltaeb
Ferrarese, Maurizio
Filippov, Alexey
Ganatra, Shashank
Garcia, Ana
García García, José María
Gayoso, Regina
Giraldo Montoya, Angela Maria
Gómez Rosso, Roscio Gómez
Gualano, Gina
Hoefsloot, Wouter
Ilievska Poposka, Biljana
Jonsson, Jerker
Khimova, Elena
Kuksa, Liga
Kunst, Heinke
Laniado Laborín, Rafael
Li, Yang
Magis Escurra, Cecile
Manfrin, Vinicio
Manga, Selene
Marchese, Valentina
Martínez Robles, Elena
Maryandyshev, Andrei
Matteelli, Alberto
Migliori, Giovanni Battista
Mullerpattan, Jai B.
Muñoz Torrico, Marcela
Mustafa Hamdan, Hamdan
Nieto Marcos, Magnolia
Noordin, Noorliza Mohamad
Palmero, Domingo Juan
Palmieri, Fabrizio
Payen, Marie Christine
Piubello, Alberto
Pontali, Emanuele
Pontarelli, Agostina
Quirós, Sarai
Rendón, Adrián
Skrahina, Alena
Smite, Agnese
Solovic, Ivan
Sotgiu, Giovanni
Souleymane, Mahamadou Bassirou
Spanevello, Antonio
Stošić, Maja
Tadolini, Marina
Tiberi, Simon
Udwadia, Zarir Farokh
Van den Boom, Martin
Vescovo, Marisa
Viggiani, Pietro
Visca, Dina
Zhurkin, Dmitry
Zignol, Matteo
Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
thumbnail https://rediab.uanl.mx/themes/sandal5/images/online.png
title Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
title_full Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
title_fullStr Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
title_full_unstemmed Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
title_short Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
title_sort surveillance of adverse events in the treatment of drug resistant tuberculosis a global feasibility study
topic RA Aspectos Públicos de la Medicina
url http://eprints.uanl.mx/23472/1/23472.pdf
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