Towards early inclusion of children in tuberculosis drugs trials: A consensus statement

Sharon Nachman*, Amina Ahmed, Farhana Amanullah, Mercedes C. Becerra, Radu Botgros, Grania Brigden, Renee Browning, Elizabeth Gardiner, Richard Hafner, Anneke Hesseling, Cleotilde How, Patrick Jean-Philippe, Erica Lessem, Mamodikoe Makhene, Nontombi Mbelle, Ben Marais, Helen McIlleron, David F. McNeeley, Carl Mendel, Stephen MurrayEileen Navarro, E. Gloria Anyalechi, Ariel R. Porcalla, Clydette Powell, Mair Powell, Mona Rigaud, Vanessa Rouzier, Pearl Samson, H. Simon Schaaf, Seema Kirti Shah, Jeff Starke, Soumya Swaminathan, Eric Wobudeya, Carol Worrell

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

54 Scopus citations

Abstract

Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained.

Original languageEnglish (US)
Pages (from-to)711-720
Number of pages10
JournalThe Lancet Infectious Diseases
Volume15
Issue number6
DOIs
StatePublished - Jun 1 2015

ASJC Scopus subject areas

  • Infectious Diseases

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