Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
•WHO recommends countries monitor the safety profile of new drugs and regimens.•WHO developed the active TB drug safety monitoring and management (aDSM) package.•aDSM data are not yet available globally.•A project to prove aDSM feasibility was launched by the Global Tuberculosis Network; 41 centres...
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| Veröffentlicht in: | International Journal of Infectious Diseases Jg. 83; S. 72 - 76 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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Canada
Elsevier Ltd
01.06.2019
Elsevier BV Elsevier |
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| ISSN: | 1201-9712, 1878-3511, 1878-3511 |
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| Abstract | •WHO recommends countries monitor the safety profile of new drugs and regimens.•WHO developed the active TB drug safety monitoring and management (aDSM) package.•aDSM data are not yet available globally.•A project to prove aDSM feasibility was launched by the Global Tuberculosis Network; 41 centres in 27 countries participated.•309 cases were fully reported as of February 2019 out of 781 cases countries committed to report in 2019.
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. |
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| AbstractList | 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.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. 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 •WHO recommends countries monitor the safety profile of new drugs and regimens.•WHO developed the active TB drug safety monitoring and management (aDSM) package.•aDSM data are not yet available globally.•A project to prove aDSM feasibility was launched by the Global Tuberculosis Network; 41 centres in 27 countries participated.•309 cases were fully reported as of February 2019 out of 781 cases countries committed to report in 2019. 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. 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. |
| Author | Rendon, Adrian van den Boom, Martin Hoefsloot, Wouter Udwadia, Zarir Farokh Cadiñanos Loidi, Julen Martínez Robles, Elena Bernal, Enrique Davies Forsman, Lina Alffenaar, Jan-Willem Skrahina, Alena Filippov, Alexey Pontarelli, Agostina Nieto Marcos, Magnolia Sotgiu, Giovanni Duarte, Raquel Visca, Dina Kuksa, Liga Tiberi, Simon Mustafa Hamdan, Hamdan Khimova, Elena Bruchfeld, Judith Tadolini, Marina Solovic, Ivan D’Ambrosio, Lia Garcia, Ana Noordin, Noorliza Mohamad Kunst, Heinke Denholm, Justin Al-Marzouqi, Nada Hassan Ganatra, Shashank Palmero, Domingo Juan García-García, José-María Mullerpattan, Jai B. Spanevello, Antonio Belilovski, Evgeny Laniado-Laborín, Rafael Pontali, Emanuele Aleksa, Alena Zignol, Matteo Manga, Selene Payen, Marie-Christine Dalcolmo, Margareth Gomez Rosso, Roscio Gomez Caminero, Jose A. Davidavičienė, Edita Matteelli, Alberto Cai, Qingshan Giraldo Montoya, Angela Maria Migliori, Giovanni Battista Maryandyshev, Andrei Munoz-Torrico, Marcela Gayoso, Regina Magis-Escurra, Cecile Manfrin, Vinicio Gualano, Gina Šmite, Ag |
| Author_xml | – sequence: 1 givenname: Onno surname: Akkerman fullname: Akkerman, Onno email: o.w.akkerman@umcg.nl organization: University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands – sequence: 2 givenname: Alena surname: Aleksa fullname: Aleksa, Alena email: alex_helen2001@mail.ru organization: Department of Phthisiology, Grodno State Medical University, GRCC “Phthisiology”, Grodno, Belarus – sequence: 3 givenname: Jan-Willem orcidid: 0000-0001-6703-0288 surname: Alffenaar fullname: Alffenaar, Jan-Willem email: j.w.c.alffenaar@umcg.nl organization: Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia – sequence: 4 givenname: Nada Hassan surname: Al-Marzouqi fullname: Al-Marzouqi, Nada Hassan email: nada.almarzouqi@moh.gov.ae organization: Preventive Medicine Department, Ministry of Health and Prevention, Dubai, United Arab Emirates – sequence: 5 givenname: Miguel surname: Arias-Guillén fullname: Arias-Guillén, Miguel email: miguelariasguillen@gmail.com organization: Servicio de Neumología, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias CIBER-Enfermedades Respiratorias. Instituto de Salud Carlos III, Oviedo Spain – sequence: 6 givenname: Evgeny surname: Belilovski fullname: Belilovski, Evgeny email: belilovsky@gmail.com organization: Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation – sequence: 7 givenname: Enrique surname: Bernal fullname: Bernal, Enrique email: ebm.hgurs@gmail.com organization: Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain – sequence: 8 givenname: Martin J. surname: Boeree fullname: Boeree, Martin J. email: Martin.Boeree@radboudumc.nl organization: Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands – sequence: 9 givenname: Sergey E. surname: Borisov fullname: Borisov, Sergey E. email: sebarsik@gmail.com organization: Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation – sequence: 10 givenname: Judith surname: Bruchfeld fullname: Bruchfeld, Judith email: judith.bruchfeld@ki.se organization: Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden – sequence: 11 givenname: Julen orcidid: 0000-0003-1555-1668 surname: Cadiñanos Loidi fullname: Cadiñanos Loidi, Julen email: julen.cadinanos@hgvillalba.es organization: Internal Medicine Department, Hospital General de Villalba, Collado Villalba, Spain – sequence: 12 givenname: Qingshan surname: Cai fullname: Cai, Qingshan email: caiqs66@163.com organization: Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China – sequence: 13 givenname: Jose A. surname: Caminero fullname: Caminero, Jose A. email: jcamlun@gobiernodecanarias.org organization: Pneumology Department, Hospital General de Gran Canaria “Dr. Negrin”, Las Palmas de Gran Canaria, Spain – sequence: 14 givenname: Jose Joaquín surname: Cebrian Gallardo fullname: Cebrian Gallardo, Jose Joaquín email: jcebrian@hcs.es organization: Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain – sequence: 15 givenname: Rosella surname: Centis fullname: Centis, Rosella email: rosella.centis@icsmaugeri.it organization: Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy – sequence: 16 givenname: Luigi Ruffo surname: Codecasa fullname: Codecasa, Luigi Ruffo email: luigiruffo.codecasa@ospedaleniguarda.it organization: TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy – sequence: 17 givenname: Lia surname: D’Ambrosio fullname: D’Ambrosio, Lia email: liadambrosio59@gmail.com organization: Public Health Consulting Group, Lugano, Switzerland – sequence: 18 givenname: Margareth surname: Dalcolmo fullname: Dalcolmo, Margareth email: margarethdalcolmo@gmail.com organization: Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil – sequence: 19 givenname: Edvardas surname: Danila fullname: Danila, Edvardas email: Edvardas.Danila@santa.lt organization: Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania – sequence: 20 givenname: Masoud surname: Dara fullname: Dara, Masoud email: daram@who.int organization: World Health Organization, Regional Office for Europe, Copenhagen, Denmark – sequence: 21 givenname: Edita surname: Davidavičienė fullname: Davidavičienė, Edita email: Edita.Davidaviciene@santa.lt organization: National TB registry, Public Health Department, Ministry of Health; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania – sequence: 22 givenname: Lina surname: Davies Forsman fullname: Davies Forsman, Lina email: lina.davies.forsman@ki.se organization: Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden – sequence: 23 givenname: Jorge surname: De Los Rios Jefe fullname: De Los Rios Jefe, Jorge email: jodelosrios@yahoo.com organization: Centro de Excelencia de TBMDR, Hospital Nacional Maria Auxiliadora, Lima, Peru – sequence: 24 givenname: Justin surname: Denholm fullname: Denholm, Justin email: justin.denholm@mh.org.au organization: Victorian Tuberculosis Program, Melbourne Health; Department of Microbiology and Immunology, University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia – sequence: 25 givenname: Raquel surname: Duarte fullname: Duarte, Raquel email: raquelafduarte@gmail.com organization: National Reference Centre for MDR-TB, Hospital Centre Vila Nova de Gaia, Department of Pneumology; Public Health Science and Medical Education Department, Faculty of Medicine, University of Porto, Porto, Portugal – sequence: 26 givenname: Seifeldin Eltaeb surname: Elamin fullname: Elamin, Seifeldin Eltaeb email: seifeldin61@gmail.com organization: MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan – sequence: 27 givenname: Maurizio surname: Ferrarese fullname: Ferrarese, Maurizio email: Maurizio.Ferrarese@ospedaleniguarda.it organization: TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy – sequence: 28 givenname: Alexey surname: Filippov fullname: Filippov, Alexey email: alex.phil.2010@yandex.ru organization: Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation – sequence: 29 givenname: Shashank surname: Ganatra fullname: Ganatra, Shashank email: shashankganatra11@gmail.com organization: Department of Respiratory Medicine, P.D. 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Muñiz, Buenos Aires, Argentina – sequence: 31 givenname: José-María surname: García-García fullname: García-García, José-María email: josemariagarciagarcia@gmail.com organization: Tuberculosis Research Programme, SEPAR, Barcelona, Spain – sequence: 32 givenname: Regina orcidid: 0000-0003-0602-4612 surname: Gayoso fullname: Gayoso, Regina email: regina.gayoso@gmail.com organization: Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil – sequence: 33 givenname: Angela Maria surname: Giraldo Montoya fullname: Giraldo Montoya, Angela Maria email: angelagiral@gmail.com organization: Sociedad Colombiana de Neumología, Universidad Tecnológica de Pereira, Pereira, Colombia – sequence: 34 givenname: Roscio Gomez surname: Gomez Rosso fullname: Gomez Rosso, Roscio Gomez email: ros-cio@hotmail.com organization: National Institute of Respiratory and Environmental Diseases “Prof. Dr. Juan Max Boettner” Asunción, Paraguay – sequence: 35 givenname: Gina orcidid: 0000-0001-6149-0005 surname: Gualano fullname: Gualano, Gina email: gina.gualano@inmi.it organization: Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy – sequence: 36 givenname: Wouter surname: Hoefsloot fullname: Hoefsloot, Wouter email: Wouter.Hoefsloot@radboudumc.nl organization: Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands – sequence: 37 givenname: Biljana surname: Ilievska-Poposka fullname: Ilievska-Poposka, Biljana email: biljana.ilievska@yahoo.com organization: National Tuberculosis Programme, Skopje, Macedonia – sequence: 38 givenname: Jerker surname: Jonsson fullname: Jonsson, Jerker email: jerker.jonsson@folkhalsomyndigheten.se organization: National TB Surveillance Unit, Public Health Agency, Stockholm, Sweden – sequence: 39 givenname: Elena surname: Khimova fullname: Khimova, Elena email: lenka.ro4eva.2013@yandex.ru organization: Northern State Medical University, Arkhangelsk, Russian Federation – sequence: 40 givenname: Liga surname: Kuksa fullname: Kuksa, Liga email: Liga.Kuksa@aslimnica.lv organization: MDR-TB department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia – sequence: 41 givenname: Heinke surname: Kunst fullname: Kunst, Heinke email: h.kunst@qmul.ac.uk organization: Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom – sequence: 42 givenname: Rafael orcidid: 0000-0003-2246-3412 surname: Laniado-Laborín fullname: Laniado-Laborín, Rafael email: rafaellaniado@gmail.com organization: Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Baja California, Mexico – sequence: 43 givenname: Yang surname: Li fullname: Li, Yang email: losty34217@gmail.com organization: Departments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China – sequence: 44 givenname: Cecile surname: Magis-Escurra fullname: Magis-Escurra, Cecile email: Cecile.Magis-Escurra@radboudumc.nl organization: Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands – sequence: 45 givenname: Vinicio surname: Manfrin fullname: Manfrin, Vinicio email: vinicio.manfrin@aulss8.veneto.it organization: S. Bortolo Hospital, Vicenza, Italy – sequence: 46 givenname: Selene surname: Manga fullname: Manga, Selene email: seleneperu@yahoo.com.mx organization: Department of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru – sequence: 47 givenname: Valentina surname: Marchese fullname: Marchese, Valentina email: v.marchese@unibs.it organization: University Department of Infectious and Tropical Diseases, WHO Collaborating Centre for TB/HIV co-infection and for TB elimination, University of Brescia and Brescia Spedali Civili General Hospital, Brescia, Italy – sequence: 48 givenname: Elena surname: Martínez Robles fullname: Martínez Robles, Elena organization: Internal Medicine Department, Tuberculosis Hospital de Cantoblanco- Hospital La Paz, Madrid, Spain – sequence: 49 givenname: Andrei surname: Maryandyshev fullname: Maryandyshev, Andrei email: maryandyshev@mail.ru organization: Northern State Medical University, Arkhangelsk, Russian Federation – sequence: 50 givenname: Alberto surname: Matteelli fullname: Matteelli, Alberto email: alberto.matteelli@unibs.it organization: University Department of Infectious and Tropical Diseases, WHO Collaborating Centre for TB/HIV co-infection and for TB elimination, University of Brescia and Brescia Spedali Civili General Hospital, Brescia, Italy – sequence: 51 givenname: Giovanni Battista orcidid: 0000-0002-2597-574X surname: Migliori fullname: Migliori, Giovanni Battista email: giovannibattista.migliori@icsmaugeri.it organization: Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy – sequence: 52 givenname: Jai B. surname: Mullerpattan fullname: Mullerpattan, Jai B. email: jaimuller@hotmail.com organization: Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India – sequence: 53 givenname: Marcela surname: Munoz-Torrico fullname: Munoz-Torrico, Marcela email: dra_munoz@hotmail.com organization: Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, Ciudad de México, Mexico – sequence: 54 givenname: Hamdan surname: Mustafa Hamdan fullname: Mustafa Hamdan, Hamdan email: drhamdanmh@gmail.com organization: MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan – sequence: 55 givenname: Magnolia surname: Nieto Marcos fullname: Nieto Marcos, Magnolia email: nmmagnolia@hotmail.com organization: Hospital Doctor Moliner, Valencia, Spain – sequence: 56 givenname: Noorliza Mohamad surname: Noordin fullname: Noordin, Noorliza Mohamad email: noorlizanoordin9@gmail.com organization: Disease Division, National Public Health Laboratory, Ministry of Health, Selangor, Malaysia – sequence: 57 givenname: Domingo Juan surname: Palmero fullname: Palmero, Domingo Juan email: djpalmero@intramed.net organization: Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina – sequence: 58 givenname: Fabrizio surname: Palmieri fullname: Palmieri, Fabrizio email: fabrizio.palmieri@inmi.it organization: Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy – sequence: 59 givenname: Marie-Christine surname: Payen fullname: Payen, Marie-Christine email: christine_payen@stpierre-bru.be organization: Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium – sequence: 60 givenname: Alberto surname: Piubello fullname: Piubello, Alberto email: albertopiubello@yahoo.it organization: Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France – sequence: 61 givenname: Emanuele surname: Pontali fullname: Pontali, Emanuele email: pontals@yahoo.com organization: Department of Infectious Diseases, Galliera Hospital, Genova, Italy – sequence: 62 givenname: Agostina surname: Pontarelli fullname: Pontarelli, Agostina email: agostinapontarelli@gmail.com organization: Reference Centre for MDR and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy – sequence: 63 givenname: Sarai surname: Quirós fullname: Quirós, Sarai email: saraiquiros@icloud.com organization: Pneumology Department, Tuberculosis Unit, Hospital de Cantoblanco- Hospital General Universitario La Paz, Madrid, Spain – sequence: 64 givenname: Adrian surname: Rendon fullname: Rendon, Adrian email: adrianrendon@hotmail.com organization: Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico – sequence: 65 givenname: Alena surname: Skrahina fullname: Skrahina, Alena email: alena.skrahina@gmail.com organization: Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus – sequence: 66 givenname: Agnese orcidid: 0000-0002-2880-3759 surname: Šmite fullname: Šmite, Agnese email: a_smite@inbox.lv organization: MDR-TB department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia – sequence: 67 givenname: Ivan surname: Solovic fullname: Solovic, Ivan email: solovic@hagy.sk organization: National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Slovakia – sequence: 68 givenname: Giovanni orcidid: 0000-0002-1600-4474 surname: Sotgiu fullname: Sotgiu, Giovanni email: gsotgiu@uniss.it organization: Clinical Epidemiology and Medical Statistics Unit, Department of z, University of Sassari, Sassari, Italy – sequence: 69 givenname: Mahamadou Bassirou surname: Souleymane fullname: Souleymane, Mahamadou Bassirou email: bachirsoul@gmail.com organization: Tuberculosis Division, Damien Foundation, Niamey, Niger – sequence: 70 givenname: Antonio surname: Spanevello fullname: Spanevello, Antonio email: antonio.spanevello@icsmaugeri.it organization: Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy – sequence: 71 givenname: Maja surname: Stošić fullname: Stošić, Maja email: maja_stosic@batut.org.rs organization: TB Programme and Surveillance Unit, National Public Health Institute, Belgrade, Serbia – sequence: 72 givenname: Marina surname: Tadolini fullname: Tadolini, Marina email: mtadolini@hotmail.com organization: Unit of Infectious Diseases, Deparment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy – sequence: 73 givenname: Simon orcidid: 0000-0001-9424-6551 surname: Tiberi fullname: Tiberi, Simon email: simon.tiberi@bartshealth.nhs.uk organization: Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom – sequence: 74 givenname: Zarir Farokh surname: Udwadia fullname: Udwadia, Zarir Farokh email: zfu@hindujahospital.com organization: Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India – sequence: 75 givenname: Martin orcidid: 0000-0002-6417-6668 surname: van den Boom fullname: van den Boom, Martin email: vandenboomm@who.int organization: World Health Organization, Regional Office for Europe, Copenhagen, Denmark – sequence: 76 givenname: Marisa surname: Vescovo fullname: Vescovo, Marisa email: marisavescovo@yahoo.com.ar organization: Pulmonology Division, Municipal Hospital F.J. 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| References_xml | – volume: 51 year: 2018 ident: bib0015 article-title: Bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis:a multi-center cohort study in Korea publication-title: Eur Respir J – volume: 47 start-page: 564 year: 2016 end-page: 574 ident: bib0040 article-title: Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis publication-title: Eur Respir J – volume: 49 year: 2017 ident: bib0005 article-title: Effectiveness and safety of bedaquiline-containing regimens in the treatment of multidrug and extensively drug-resistant tuberculosis: a multicentre study publication-title: Eur Respir J – volume: 52 year: 2018 ident: bib0035 article-title: Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review publication-title: Eur Respir J – volume: 44 start-page: 347 year: 2018 end-page: 349 ident: bib0045 article-title: Global TB Network: working together to eliminate tuberculosis publication-title: J Bras Pneumol – year: 2015 ident: bib0050 article-title: Active TB drug-safety monitoring and management (aDSM). WHO/HTM/TB/2015.28 – volume: 50 year: 2017 ident: bib0020 article-title: Final treatment outcomes of multidrug and extensively drug-resistant tuberculosis patients in Latvia receiving delamanid-containing regimens publication-title: Eur Respir J – volume: 51 year: 2018 ident: bib0025 article-title: Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa publication-title: Eur Respir J – volume: 51 year: 2018 ident: bib0010 article-title: The World Health Organization global aDSM database: generating evidence on the safety of new treatment regimens for drug-resistant tuberculosis publication-title: Eur Respir J – volume: 50 year: 2017 ident: bib0030 article-title: Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence publication-title: Eur Respir J – volume: 47 start-page: 564 issue: 2 year: 2016 ident: 10.1016/j.ijid.2019.03.036_bib0040 article-title: Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis publication-title: Eur Respir J doi: 10.1183/13993003.00724-2015 – volume: 51 issue: 6 year: 2018 ident: 10.1016/j.ijid.2019.03.036_bib0025 article-title: Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa publication-title: Eur Respir J doi: 10.1183/13993003.00017-2018 – volume: 51 year: 2018 ident: 10.1016/j.ijid.2019.03.036_bib0015 article-title: Bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis:a multi-center cohort study in Korea publication-title: Eur Respir J doi: 10.1183/13993003.02467-2017 – volume: 49 issue: 5 year: 2017 ident: 10.1016/j.ijid.2019.03.036_bib0005 article-title: Effectiveness and safety of bedaquiline-containing regimens in the treatment of multidrug and extensively drug-resistant tuberculosis: a multicentre study publication-title: Eur Respir J doi: 10.1183/13993003.00387-2017 – volume: 52 issue: 1 year: 2018 ident: 10.1016/j.ijid.2019.03.036_bib0035 article-title: Combined treatment of drug-resistant tuberculosis with bedaquiline and delamanid: a systematic review publication-title: Eur Respir J doi: 10.1183/13993003.00934-2018 – volume: 50 issue: 5 year: 2017 ident: 10.1016/j.ijid.2019.03.036_bib0020 article-title: Final treatment outcomes of multidrug and extensively drug-resistant tuberculosis patients in Latvia receiving delamanid-containing regimens publication-title: Eur Respir J doi: 10.1183/13993003.01105-2017 – year: 2015 ident: 10.1016/j.ijid.2019.03.036_bib0050 – volume: 51 year: 2018 ident: 10.1016/j.ijid.2019.03.036_bib0010 article-title: The World Health Organization global aDSM database: generating evidence on the safety of new treatment regimens for drug-resistant tuberculosis publication-title: Eur Respir J doi: 10.1183/13993003.01643-2017 – volume: 50 issue: 5 year: 2017 ident: 10.1016/j.ijid.2019.03.036_bib0030 article-title: Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence publication-title: Eur Respir J doi: 10.1183/13993003.01462-2017 – volume: 44 start-page: 347 issue: 5 year: 2018 ident: 10.1016/j.ijid.2019.03.036_bib0045 article-title: Global TB Network: working together to eliminate tuberculosis publication-title: J Bras Pneumol doi: 10.1590/s1806-37562018000000279 |
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| SubjectTerms | Adverse events Adverse events; Bedaquiline; Delamanid; MDR-TB; Monitoring; Tuberculosis Adverse events; Bedaquiline; Delamanid; MDR-TB; Monitoring; Tuberculosis; Antitubercular Agents; Diarylquinolines; Drug Therapy, Combination; Feasibility Studies; Female; Humans; Male; Nitroimidazoles; Oxazoles; Pilot Projects; Tuberculosis; Tuberculosis, Multidrug-Resistant; World Health Organization Antitubercular Agents Bedaquiline Delamanid Diarylquinolines Drug Therapy, Combination Feasibility Studies Female Humans Infectious and parasitic diseases Male MDR-TB Microbiologie et protistologie [bacteriol.virolog.mycolog.] Microbiologie et protistologie [entomologie,phytoparasitolog.] Microbiologie et protistologie [parasitologie hum. et anim.] Monitoring Nitroimidazoles Oxazoles Pathologie maladies infectieuses Pilot Projects RA Aspectos Públicos de la Medicina Radboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences RC109-216 Tuberculosis Tuberculosis, Multidrug-Resistant World Health Organization |
| Title | Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study |
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