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 eff ective, are hampered by
high pill burden, long duration of treatment, coexistent toxic eff ects, 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.
Ismail, Nazir Ahmed; Mvusi, Lindiwe; Nanoo, Ananta; Dreyer, Andries; Omar, Shaheed V.; Babatunde, Sanni; Molebatsi, Thabo; Van der Walt, Martie; Adelekan, Adeboye; Deyde, Varough; Ihekweazu, Chikwe; Madhi, S.A.(Elsevier, 2018-07)
BACKGROUND : Globally, per-capita, South Africa reports a disproportionately high number of cases of multidrug-resistant (MDR) tuberculosis and extensively drug-resistant (XDR) tuberculosis. We sought to estimate the ...
Nliwasa, Marriott; MacPherson, Peter; Gupta-Wright, Ankur; Mwapasa, Mphatso; Horton, Katherine; Odland, Jon Oyvind; Flach, Clare; Corbett, Elizabeth L.(Wiley Open Access, 2018-07)
INTRODUCTION : HIV and tuberculosis (TB) remain leading causes of preventable death in low- and middle-income countries
(LMICs). The World Health Organization (WHO) recommends HIV testing for all individuals with TB ...