The assessment of new anti-tuberculosis drugs for a paediatric indication

Date
2007
Authors
Donald P.R.
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Volume Title
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Abstract
For the first time in three decades there is a promising pipeline of more than 20 new anti-tuberculosis agents at various stages of development, and several are already entering early clinical trials. Childhood tuberculosis (TB) comprises a significant part of the TB caseload, particularly in developing communities. There is, nonetheless, as yet no agreed pathway for the assessment of anti-tuberculosis agents in children. The feasibility of assessing an anti-tuberculosis agent in a childhood population is discussed in the present study, and it is concluded that it would be very difficult to assess the efficacy of an anti-tuberculosis agent in children due to the wide spectrum of diseases encountered in children and the lack of objective criteria to assess the response to treatment. However, it is essential that the pharmacokinetics and toxicity of any new agent should be assessed in a population of children over a range of ages. © 2007 The Union.
Description
Keywords
chloramphenicol, isoniazid, pyrazinamide, tuberculostatic agent, child care, clinical assessment, drug efficacy, drug half life, human, incidence, lung tuberculosis, miliary tuberculosis, Mycobacterium tuberculosis, priority journal, review, treatment indication, treatment outcome, treatment response, tuberculous meningitis, unspecified side effect, Adolescent, Antitubercular Agents, Child, Clinical Trials as Topic, Humans, Tuberculosis
Citation
International Journal of Tuberculosis and Lung Disease
11
11