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. 2022 Jun 29;11(4):1327–1341. doi: 10.1007/s40121-022-00667-z
Tuberculous meningitis (TBM) is the most severe and disabling form of tuberculosis.
The INTENSE-TBM project includes a phase III randomised clinical trial on TBM in sub-Saharan Africa. Using a factorial design, the INTENSE-TBM is evaluating the efficacy of an intensified anti-tubercular treatment (increased rifampicin dose and added linezolid during intensive phase vs. WHO standard regimen) and an anti-inflammatory treatment (aspirin vs. placebo), with a view to reducing TBM mortality and morbidity in patients co-infected/not co-infected with human immunodeficiency virus (HIV).
We aimed to design a comprehensive work-package on capacity building, ensuring all centres would acquire the ability to conduct a phase III randomised clinical trial on TBM in sub-Saharan Africa.
The initiation of the INTENSE-TBM clinical trial was achieved at all sites - despite major challenges imposed by the coronavirus disease 2019 (COVID-19) pandemic - enhancing local healthcare systems and encouraging further clinical research in sub-Saharan Africa.