It is estimated that one third of the world's population is infected with Mycobacterium tuberculosis (the bacterium that causes tuberculosis (TB)), and that each year, about 9 million people develop TB, of whom about 2 million die. Of the 9 million annual TB cases, about 1 million (11%) occur in children (under 15 years of age). Of these childhood cases, 75% occur annually in 22 high-burden countries that together account for 80% of the world's estimated incident cases. In countries worldwide, the reported percentage of all TB cases occurring in children varies from 3% to more than 25%. The Stop TB Strategy, which builds on the DOTS strategy developed by the World Health Organization (WHO) and the International Union Against TB and Lung Disease, has a critical role in reducing the worldwide burden of disease and thus in protecting children from infection and disease. The management of children with TB should be in line with the Stop TB Strategy, taking into consideration the particular epidemiology and clinical presentation of TB in children. These consensus guidelines were produced to help the National Tuberculosis Programmes on the management of tuberculosis in children.

Between 2011 and 2019, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO Consolidated Guidelines on Drug Resistant Tuberculosis Treatment, issued by WHO in March 2019. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups, using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present WHO Consolidated Guidelines on Tuberculosis, Module 4: Treatment - Drug-Resistant Tuberculosis Treatment includes a comprehensive set of WHO recommendations for the treatment and care of DR-TB. The document includes two new recommendations, one on the composition of shorter regimens and one on the use of the BPaL regimen (i.e. bedaquiline, pretomanid and linezolid). In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB and MDR/RR-TB, including longer regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), the use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care. The guidelines are to be used primarily in national TB programmes, or their equivalents in Ministries of Health, and for other policy-makers and technical organizations working on TB and infectious diseases in public and private sectors and in the community.

Paediatric drug optimization (PADO) exercises have been convened by the World Health Organization (WHO) for various diseases, demonstrating their potential and impact to accelerate access to optimal formulations in the context of fragmented small markets for medicines for children. The WHO Global Tuberculosis Programme has convened PADO-TB meetings since February 2019 (PADO-TB1), followed by an interim review of the PADO-TB1 priorities in September 2020. Optimization of paediatric TB medicines forms part of the key actions in the Roadmap towards ending TB in children and adolescents, third edition and contributes to the achievement of the targets for ending TB in children and adolescents set out at the second United Nations High-level Meeting on the Fight Against TB in 2023. Considering the latest WHO recommendations on drug-susceptible TB, drug-resistant TB and TB preventive treatment, recent developments in new TB medicines and formulations made available, results of clinical trials and studies, and advancements of key medicines in the TB R&D pipeline, WHO convened the second PADO-TB meeting (PADO-TB2) on 3–5 October 2023. This meeting report summarizes the proceedings, discussions and the main consensus-based outputs of the PADO-TB2 meeting: - PADO-TB2 priority list (priority formulations to be investigated/developed in the short term and essential formulations to be developed in the longer term) - PADO-TB2 watch list (promising candidates for investigation/development for children within 5–10 years) - Priority research questions.

The Paediatric Antituberculosis Drug Optimization (PADO-TB) meetings provide a forum for clinicians, researchers, financial and technical partners and other relevant key stakeholders to work together, to ensure that priority optimal paediatric formulations of TB medicines are investigated, developed and made available to children in a timely manner. After the first meeting (PADO-TB1) in February 2019, WHO hosted an interim review of the PADO-TB1 priorities. The review considered the latest WHO recommendations and other relevant developments since February 2019, such as results of clinical trials, results of pharmacokinetics and pharmacodynamics studies, new formulations available and advancements of key drugs in the TB research and development pipeline. The 4.5-hour virtual review was attended by more than 50 experts including clinicians, researchers, representatives of national TB programmes (NTPs) from high TB burden countries, community representatives, financial and technical partners, members of the Child and Adolescent TB Working Group and representatives from various international agencies, including WHO. This report summarizes the main developments presented for various TB medicines and the decisions taken with regard to the PADO-TB priority list.

The aim of this operational handbook is to provide practical guidance on the implementation of the World Health Organization (WHO) policy recommendations on the prevention and management of TB in children and adolescents under programmatic circumstances and at different levels of the health system. The practical guidance aims to inform the development or revision of national policies and related implementation guidance (e.g. handbooks, standard operating procedures) on the management of TB in children and adolescents. This handbook can also help countries adequately plan for the uptake of interventions to better address the specific needs of children and adolescents with or at risk of TB. It can contribute to national efforts to build capacity among national and subnational programme managers and among health workers at all levels of the health care system. The target audience for this handbook includes NTPs and other child health programmes that provide care for children with or at risk of TB, including maternal, newborn, child and adolescent health programmes, HIV services, and PHC programmes. The handbook also targets paediatricians and other health care workers (HCWs) in the public and private sectors, school health services, civil society and community-based organizations, and health care educators.