Clinical standards for drug-susceptible pulmonary TB

doi:10.5588/ijtld.22.0228

. 2022 Jul 1;26(7):592-604.

doi: 10.5588/ijtld.22.0228.

Clinical standards for drug-susceptible pulmonary TB

O W Akkerman¹, R Duarte², S Tiberi³, H S Schaaf⁴, C Lange⁵, J W C Alffenaar⁶, J Denholm⁷, A C C Carvalho⁸, M S Bolhuis⁹, S Borisov¹⁰, J Bruchfeld¹¹, A M Cabibbe¹², J A Caminero¹³, I Carvalho¹⁴, J Chakaya¹⁵, R Centis¹⁶, M P Dalcomo¹⁷, L D Ambrosio¹⁸, M Dedicoat¹⁹, K Dheda²⁰, K E Dooley²¹, J Furin²², J-M García-García²³, N A H van Hest²⁴, B C de Jong²⁵, X Kurhasani²⁶, A G Märtson²⁷, S Mpagama²⁸, M Munoz Torrico²⁹, E Nunes³⁰, C W M Ong³¹, D J Palmero³², R Ruslami³³, A M I Saktiawati³⁴, C Semuto³⁵, D R Silva³⁶, R Singla³⁷, I Solovic³⁸, S Srivastava³⁹, J E M de Steenwinkel⁴⁰, A Story⁴¹, M G G Sturkenboom⁹, M Tadolini⁴², Z F Udwadia⁴³, A R Verhage⁴⁴, J P Zellweger⁴⁵, G B Migliori¹⁶

Affiliations

¹ TB Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands, Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
² Centro Hospitalar de Vila Nova de Gaia/Espinho; Instituto de Ciencias Biomédicas de Abel Saalazar, Universidade do Porto, Instituto de Saúde Publica da Universidade do Porto, Unidade de Investigação Clínica, ARS Norte, Porto, Portugal.
³ Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Division of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK.
⁴ Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
⁵ Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany, German Center for Infection Research (DZIF) Clinical Tuberculosis Unit, Borstel, Germany, Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany, The Global Tuberculosis Program, Texas Children´s Hospital, Immigrant and Global Health, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
⁶ Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW, Australia, School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia.
⁷ Victorian Tuberculosis Program, Melbourne Health, Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
⁸ Laboratório de Inovações em Terapias, Ensino e Bioprodutos, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.
⁹ Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
¹⁰ Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia.
¹¹ Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden, Department of Infectious Disease, Karolinska University Hospital, Stockholm, Sweden.
¹² Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy.
¹³ Department of Pneumology, University General Hospital of Gran Canaria "Dr Negrin", Las Palmas, Spain, ALOSA (Active Learning over Sanitary Aspects) TB Academy, Spain.
¹⁴ Pediatric Department, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia, Portugal.
¹⁵ Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya, Department of Clinical Sciences. Liverpool School of Tropical Medicine, Liverpool, UK.
¹⁶ Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy.
¹⁷ Reference Center Helio Fraga, FIOCRUZ, Brazil.
¹⁸ Public Health Consulting Group, Lugano, Switzerland.
¹⁹ Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
²⁰ Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa, South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
²¹ Center for Tuberculosis Research, Johns Hopkins, Baltimore, MD.
²² Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
²³ Tuberculosis Research Programme SEPAR, E-08029 Barcelona, Spain.
²⁴ Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands, Municipal Public Health Service Groningen, Groningen, The Netherlands.
²⁵ Mycobacteriology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
²⁶ UBT-Higher Education Institution Prishtina, Kosovo.
²⁷ Antimicrobial Pharmacodynamics and Therapeutics, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
²⁸ Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzani, Kibong´oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania.
²⁹ Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas, México City, Mexico.
³⁰ Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique, Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique.
³¹ Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore, Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.
³² Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
³³ Department of Biomedical Science, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia, Research Center for Care and Control of Infectious Disease (RC3iD), Universitas Padjadjaran, Bandung, Indonesia.
³⁴ Department of Internal Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia, Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
³⁵ Research, Innovation and Data Science Division, Rwanda Biomedical Center, Kigali, Rwanda.
³⁶ Instituto Vaccarezza, Hospital Muñiz, Buenos Aires, Argentina.
³⁷ National Institute of Tuberculosis & Respiratory Diseases, New Delhi, India.
³⁸ National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia.
³⁹ Department of Pulmonary Immunology, University of Texas Health Science Centre at Tyler, Tyler, TX, USA.
⁴⁰ Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands.
⁴¹ Institute of Epidemiology and Healthcare, University College London, London, UK, Find and Treat, University College Hospitals NHS Foundation Trust, London, UK.
⁴² Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
⁴³ P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India.
⁴⁴ Department of Pediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
⁴⁵ TB Competence Center, Swiss Lung Association, Berne, Switzerland.

PMID: 35768923
PMCID: PMC9272737
DOI: 10.5588/ijtld.22.0228

Clinical standards for drug-susceptible pulmonary TB

O W Akkerman et al. Int J Tuberc Lung Dis. 2022.

. 2022 Jul 1;26(7):592-604.

doi: 10.5588/ijtld.22.0228.

Authors

Affiliations

¹ TB Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands, Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
² Centro Hospitalar de Vila Nova de Gaia/Espinho; Instituto de Ciencias Biomédicas de Abel Saalazar, Universidade do Porto, Instituto de Saúde Publica da Universidade do Porto, Unidade de Investigação Clínica, ARS Norte, Porto, Portugal.
³ Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Division of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK.
⁴ Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
⁵ Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany, German Center for Infection Research (DZIF) Clinical Tuberculosis Unit, Borstel, Germany, Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany, The Global Tuberculosis Program, Texas Children´s Hospital, Immigrant and Global Health, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
⁶ Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW, Australia, School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia.
⁷ Victorian Tuberculosis Program, Melbourne Health, Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
⁸ Laboratório de Inovações em Terapias, Ensino e Bioprodutos, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil.
⁹ Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
¹⁰ Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia.
¹¹ Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden, Department of Infectious Disease, Karolinska University Hospital, Stockholm, Sweden.
¹² Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy.
¹³ Department of Pneumology, University General Hospital of Gran Canaria "Dr Negrin", Las Palmas, Spain, ALOSA (Active Learning over Sanitary Aspects) TB Academy, Spain.
¹⁴ Pediatric Department, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia, Portugal.
¹⁵ Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya, Department of Clinical Sciences. Liverpool School of Tropical Medicine, Liverpool, UK.
¹⁶ Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy.
¹⁷ Reference Center Helio Fraga, FIOCRUZ, Brazil.
¹⁸ Public Health Consulting Group, Lugano, Switzerland.
¹⁹ Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
²⁰ Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa, South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.
²¹ Center for Tuberculosis Research, Johns Hopkins, Baltimore, MD.
²² Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
²³ Tuberculosis Research Programme SEPAR, E-08029 Barcelona, Spain.
²⁴ Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands, Municipal Public Health Service Groningen, Groningen, The Netherlands.
²⁵ Mycobacteriology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
²⁶ UBT-Higher Education Institution Prishtina, Kosovo.
²⁷ Antimicrobial Pharmacodynamics and Therapeutics, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
²⁸ Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzani, Kibong´oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania.
²⁹ Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas, México City, Mexico.
³⁰ Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique, Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique.
³¹ Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore, Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.
³² Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
³³ Department of Biomedical Science, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia, Research Center for Care and Control of Infectious Disease (RC3iD), Universitas Padjadjaran, Bandung, Indonesia.
³⁴ Department of Internal Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia, Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
³⁵ Research, Innovation and Data Science Division, Rwanda Biomedical Center, Kigali, Rwanda.
³⁶ Instituto Vaccarezza, Hospital Muñiz, Buenos Aires, Argentina.
³⁷ National Institute of Tuberculosis & Respiratory Diseases, New Delhi, India.
³⁸ National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia.
³⁹ Department of Pulmonary Immunology, University of Texas Health Science Centre at Tyler, Tyler, TX, USA.
⁴⁰ Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands.
⁴¹ Institute of Epidemiology and Healthcare, University College London, London, UK, Find and Treat, University College Hospitals NHS Foundation Trust, London, UK.
⁴² Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
⁴³ P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India.
⁴⁴ Department of Pediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
⁴⁵ TB Competence Center, Swiss Lung Association, Berne, Switzerland.

PMID: 35768923
PMCID: PMC9272737
DOI: 10.5588/ijtld.22.0228

Abstract
in English, French

BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice´ for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB).METHODS: A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants.RESULTS: Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB.CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

CONTEXTE:: L’objectif de ces normes cliniques est de fournir des conseils sur les “meilleures pratiques” en matière de diagnostic, de traitement et de prise en charge de la tuberculose pulmonaire (PTB) pharmacosensible.

MÉTHODES:: Un panel de 54 experts mondiaux dans le domaine des soins antituberculeux, de la santé publique, de la microbiologie et de la pharmacologie a été identifié ; 46 ont participé à un processus Delphi. Une échelle de Likert en 5 points a été utilisée pour noter les projets de normes. Le document final représente le large consensus et a été approuvé par les 46 participants.

RÉSULTATS:: Sept normes cliniques ont été définies : Norme 1, tous les patients (adultes ou enfants) qui présentent des symptômes et des signes compatibles avec une PTB doivent subir des examens pour parvenir à un diagnostic ; Norme 2, des tests bactériologiques adéquats doivent être effectués pour exclure une TB résistante aux médicaments ; Norme 3, un régime convenable recommandé par l’OMS et les directives nationales pour le traitement de la PTB doit être identifié ; Norme 4, une éducation et des conseils sur la santé doivent être dispensés à chaque patient commençant le traitement ; Norme 5, un suivi du traitement doit être effectué pour évaluer l’adhésion, suivre les progrès du patient, identifier et gérer les effets indésirables et détecter le développement de la résistance ; Norme 6, une série recommandée d’examens du patient doit être effectuée à la fin du traitement ; Norme 7, les actions de santé publique nécessaires doivent être menées pour chaque patient. Nous avons également identifié les priorités pour les recherches futures sur la PTB.

CONCLUSION:: Ces normes cliniques consensuelles contribueront à améliorer la prise en charge des patients en guidant les cliniciens et les responsables de programmes dans la planification et la mise en œuvre de mesures localement appropriées pour un traitement optimal de la PTB centré sur la personne.

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References

1. World Health Organization Geneva, Switzerland: 2021. Global tuberculosis report, 2021.
1. World Health Organization Geneva, Switzerland: WHO; 2014. The End TB Strategy. Global strategy and targets for tuberculosis prevention, care and control after 2015.
1. Nahid P, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: Treatment of drug-susceptible tuberculosis. Clin Infect Dis. 2016;63:e147–e195. - PMC - PubMed
1. Trentalange A, et al. Rifampicin and isoniazid maximal concentrations are below efficacy-associated thresholds in the majority of patients: time to increase the doses. Int J Antimicrob Agents. 2021;57:106297. - PubMed
1. Muliaditan M, Della Pasqua O. How long will treatment guidelines for TB continue to overlook variability in drug exposure. J Antimicrob Chemother. 2019;74:3274–3280. - PMC - PubMed

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[1] World Health Organization Geneva, Switzerland: 2021. Global tuberculosis report, 2021.

[2] World Health Organization Geneva, Switzerland: 2021. Global tuberculosis report, 2021.

[3] World Health Organization Geneva, Switzerland: WHO; 2014. The End TB Strategy. Global strategy and targets for tuberculosis prevention, care and control after 2015.

[4] World Health Organization Geneva, Switzerland: WHO; 2014. The End TB Strategy. Global strategy and targets for tuberculosis prevention, care and control after 2015.

[5] Nahid P, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: Treatment of drug-susceptible tuberculosis. Clin Infect Dis. 2016;63:e147–e195. - PMC - PubMed

[6] Nahid P, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: Treatment of drug-susceptible tuberculosis. Clin Infect Dis. 2016;63:e147–e195. - PMC - PubMed

[7] Trentalange A, et al. Rifampicin and isoniazid maximal concentrations are below efficacy-associated thresholds in the majority of patients: time to increase the doses. Int J Antimicrob Agents. 2021;57:106297. - PubMed

[8] Trentalange A, et al. Rifampicin and isoniazid maximal concentrations are below efficacy-associated thresholds in the majority of patients: time to increase the doses. Int J Antimicrob Agents. 2021;57:106297. - PubMed

[9] Muliaditan M, Della Pasqua O. How long will treatment guidelines for TB continue to overlook variability in drug exposure. J Antimicrob Chemother. 2019;74:3274–3280. - PMC - PubMed

[10] Muliaditan M, Della Pasqua O. How long will treatment guidelines for TB continue to overlook variability in drug exposure. J Antimicrob Chemother. 2019;74:3274–3280. - PMC - PubMed

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Clinical standards for drug-susceptible pulmonary TB

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Clinical standards for drug-susceptible pulmonary TB

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Abstract
in English, French