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.

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.

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 document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.

Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, 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 treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. The present Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, including longer and shorter 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), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.

This work contains updated and clinically relevant information about tuberculosis. It is aimed at providing a succinct overview of history and disease epidemiology, clinical presentation and the most recent scientific developments in the field of tuberculosis research, with an emphasis on diagnosis and treatment. It may serve as a practical resource for students, clinicians and researchers who work in the field of infectious diseases.

Tuberculosis (TB) remains one of the major infectious diseases of mankind although drugs for its treatment have been available for nearly 60 years. The standard short-course 6-month regimen used since about 1980 has helped to save millions of lives, but co-infection with HIV has had a devastating effect on the epidemic, and multidrug-resistant TB is a growing problem, particularly in communities with a high incidence of HIV. Following the declaration by the WHO in the early 1990s that TB was a 'global health emergency', interest in TB research and the development of new drugs has increased significantly. This volume reviews anti-TB chemotherapy with the emphasis on the actions and pharmacology of existing drugs and the development and evaluation of new agents. A close look is taken at new research regarding our existing drugs by some of the best-known specialists in the field, and historical aspects of these agents are reviewed from a modern perspective. The prospects for the introduction of new drugs and different approaches of how to assess them in adults and in children are discussed in detail. Several papers address the problems associated with drug resistance, its spread and diagnosis. Compiled by two editors from Cape Town, which has a particularly high incidence of TB and is a centre of tuberculosis research, this publication is an indispensable reference for anyone involved in the management of TB either as a researcher, clinician or administrator, and those working in drug development.