International Journal of Infectious Diseases (Jun 2019)
Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study
- Onno Akkerman,
- Alena Aleksa,
- Jan-Willem Alffenaar,
- Nada Hassan Al-Marzouqi,
- Miguel Arias-Guillén,
- Evgeny Belilovski,
- Enrique Bernal,
- Martin J. Boeree,
- Sergey E. Borisov,
- Judith Bruchfeld,
- Julen Cadiñanos Loidi,
- Qingshan Cai,
- Jose A. Caminero,
- Jose Joaquín Cebrian Gallardo,
- Rosella Centis,
- Luigi Ruffo Codecasa,
- Lia D’Ambrosio,
- Margareth Dalcolmo,
- Edvardas Danila,
- Masoud Dara,
- Edita Davidavičienė,
- Lina Davies Forsman,
- Jorge De Los Rios Jefe,
- Justin Denholm,
- Raquel Duarte,
- Seifeldin Eltaeb Elamin,
- Maurizio Ferrarese,
- Alexey Filippov,
- Shashank Ganatra,
- Ana Garcia,
- José-María García-García,
- Regina Gayoso,
- Angela Maria Giraldo Montoya,
- Roscio Gomez Gomez Rosso,
- Gina Gualano,
- Wouter Hoefsloot,
- Biljana Ilievska-Poposka,
- Jerker Jonsson,
- Elena Khimova,
- Liga Kuksa,
- Heinke Kunst,
- Rafael Laniado-Laborín,
- Yang Li,
- Cecile Magis-Escurra,
- Vinicio Manfrin,
- Selene Manga,
- Valentina Marchese,
- Elena Martínez Robles,
- Andrei Maryandyshev,
- Alberto Matteelli,
- Giovanni Battista Migliori,
- Jai B. Mullerpattan,
- Marcela Munoz-Torrico,
- Hamdan Mustafa Hamdan,
- Magnolia Nieto Marcos,
- Noorliza Mohamad Noordin,
- Domingo Juan Palmero,
- Fabrizio Palmieri,
- Marie-Christine Payen,
- Alberto Piubello,
- Emanuele Pontali,
- Agostina Pontarelli,
- Sarai Quirós,
- Adrian Rendon,
- Alena Skrahina,
- Agnese Šmite,
- Ivan Solovic,
- Giovanni Sotgiu,
- Mahamadou Bassirou Souleymane,
- Antonio Spanevello,
- Maja Stošić,
- Marina Tadolini,
- Simon Tiberi,
- Zarir Farokh Udwadia,
- Martin van den Boom,
- Marisa Vescovo,
- Pietro Viggiani,
- Dina Visca,
- Dmitry Zhurkin,
- Matteo Zignol
Affiliations
- Onno Akkerman
- University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases & Tuberculosis, Groningen, The Netherlands
- Alena Aleksa
- Department of Phthisiology, Grodno State Medical University, GRCC “Phthisiology”, Grodno, Belarus
- Jan-Willem Alffenaar
- Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Westmead Hospital, Sydney, Australia; Dept. Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
- Nada Hassan Al-Marzouqi
- Preventive Medicine Department, Ministry of Health and Prevention, Dubai, United Arab Emirates
- Miguel Arias-Guillén
- 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
- Evgeny Belilovski
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- Enrique Bernal
- Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain
- Martin J. Boeree
- Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands
- Sergey E. Borisov
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- Judith Bruchfeld
- Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
- Julen Cadiñanos Loidi
- Internal Medicine Department, Hospital General de Villalba, Collado Villalba, Spain
- Qingshan Cai
- Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China
- Jose A. Caminero
- Pneumology Department, Hospital General de Gran Canaria “Dr. Negrin”, Las Palmas de Gran Canaria, Spain; MDR-TB Unit, Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France
- Jose Joaquín Cebrian Gallardo
- Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain
- Rosella Centis
- Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
- Luigi Ruffo Codecasa
- TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy
- Lia D’Ambrosio
- Public Health Consulting Group, Lugano, Switzerland
- Margareth Dalcolmo
- Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
- Edvardas Danila
- Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- Masoud Dara
- World Health Organization, Regional Office for Europe, Copenhagen, Denmark
- Edita Davidavičienė
- National TB registry, Public Health Department, Ministry of Health; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
- Lina Davies Forsman
- Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
- Jorge De Los Rios Jefe
- Centro de Excelencia de TBMDR, Hospital Nacional Maria Auxiliadora, Lima, Peru
- Justin Denholm
- Victorian Tuberculosis Program, Melbourne Health; Department of Microbiology and Immunology, University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
- Raquel Duarte
- 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
- Seifeldin Eltaeb Elamin
- MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan
- Maurizio Ferrarese
- TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy
- Alexey Filippov
- Moscow Research and Clinical Center for TB Control, Moscow Government’s Health Department, Moscow, Russian Federation
- Shashank Ganatra
- Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India
- Ana Garcia
- Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
- José-María García-García
- Tuberculosis Research Programme, SEPAR, Barcelona, Spain
- Regina Gayoso
- Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
- Angela Maria Giraldo Montoya
- Sociedad Colombiana de Neumología, Universidad Tecnológica de Pereira, Pereira, Colombia
- Roscio Gomez Gomez Rosso
- National Institute of Respiratory and Environmental Diseases “Prof. Dr. Juan Max Boettner” Asunción, Paraguay
- Gina Gualano
- Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy
- Wouter Hoefsloot
- Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands
- Biljana Ilievska-Poposka
- National Tuberculosis Programme, Skopje, Macedonia
- Jerker Jonsson
- National TB Surveillance Unit, Public Health Agency, Stockholm, Sweden
- Elena Khimova
- Northern State Medical University, Arkhangelsk, Russian Federation
- Liga Kuksa
- MDR-TB department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
- Heinke Kunst
- Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
- Rafael Laniado-Laborín
- Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Baja California, Mexico
- Yang Li
- Departments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China
- Cecile Magis-Escurra
- Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands
- Vinicio Manfrin
- S. Bortolo Hospital, Vicenza, Italy
- Selene Manga
- Department of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru
- Valentina Marchese
- 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
- Elena Martínez Robles
- Internal Medicine Department, Tuberculosis Hospital de Cantoblanco- Hospital La Paz, Madrid, Spain
- Andrei Maryandyshev
- Northern State Medical University, Arkhangelsk, Russian Federation
- Alberto Matteelli
- 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
- Giovanni Battista Migliori
- Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy; Corresponding author at: Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Via Roncaccio 16, Tradate, Varese, 21049, Italy.
- Jai B. Mullerpattan
- Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India
- Marcela Munoz-Torrico
- Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias, Ciudad de México, Mexico
- Hamdan Mustafa Hamdan
- MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan
- Magnolia Nieto Marcos
- Hospital Doctor Moliner, Valencia, Spain
- Noorliza Mohamad Noordin
- Disease Division, National Public Health Laboratory, Ministry of Health, Selangor, Malaysia
- Domingo Juan Palmero
- Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
- Fabrizio Palmieri
- Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases ‘L. Spallanzani’, IRCCS, Rome, Italy
- Marie-Christine Payen
- Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium
- Alberto Piubello
- Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France; Tuberculosis Division, Damien Foundation, Niamey, Niger
- Emanuele Pontali
- Department of Infectious Diseases, Galliera Hospital, Genova, Italy
- Agostina Pontarelli
- Reference Centre for MDR and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy
- Sarai Quirós
- Pneumology Department, Tuberculosis Unit, Hospital de Cantoblanco- Hospital General Universitario La Paz, Madrid, Spain
- Adrian Rendon
- Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico
- Alena Skrahina
- Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
- Agnese Šmite
- MDR-TB department, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
- Ivan Solovic
- National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Slovakia
- Giovanni Sotgiu
- Clinical Epidemiology and Medical Statistics Unit, Department of z, University of Sassari, Sassari, Italy
- Mahamadou Bassirou Souleymane
- Tuberculosis Division, Damien Foundation, Niamey, Niger
- Antonio Spanevello
- Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy; Department of Medicine and Surgery, Respiratory Diseases, University of Insubria, Varese, Italy
- Maja Stošić
- TB Programme and Surveillance Unit, National Public Health Institute, Belgrade, Serbia
- Marina Tadolini
- Unit of Infectious Diseases, Deparment of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy
- Simon Tiberi
- Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; Division of Infection, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom
- Zarir Farokh Udwadia
- Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India
- Martin van den Boom
- World Health Organization, Regional Office for Europe, Copenhagen, Denmark
- Marisa Vescovo
- Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
- Pietro Viggiani
- Reference Centre for MDR and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy
- Dina Visca
- Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy; Department of Medicine and Surgery, Respiratory Diseases, University of Insubria, Varese, Italy
- Dmitry Zhurkin
- Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
- Matteo Zignol
- Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland
- Journal volume & issue
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Vol. 83
pp. 72 – 76
Abstract
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
