Syracuse

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial

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Patil, S, B | Tamirat, M. | Khazhidinov, K. | Ardizzoni, E. | Atger, M. | Austin, A. | Baudin, E. | Bekhit, M. | Bektasov, S. | Berikova, E. | Bonnet, M. | Caboclo, R. | Chaudhry, M. | Chavan, V. | Cloez, S. | Coit, J. | Coutisson, S. | Dakenova, Z. | de Jong, B, C | Delifer, C. | Demaisons, S. | Do, J, M | dos Santos Tozzi, D. | Ducher, V. | Ferlazzo, G. | Gouillou, M. | Khan, U. | Kunda, M. | Lachenal, N. | Lahood, A, N | Lecca, L. | Mazmanian, M. | Mcilleron, H. | Moreau, M. | Moschioni, M. | Nahid, P. | Osso, E. | Oyewusi, L. | Panda, S. | Pâquet, A. | Thuong Huu, P. | Pichon, L. | Rich, M, L | Rupasinghe, P. | Salahuddin, N. | Sanchez Garavito, E. | Seung, K, J | Velásquez, G, E | Vallet, M. | Varaine, F. | Yuya-Septoh, F, J | Mitnick, C, D | Guglielmetti, L.

Edité par CCSD ; BioMed Central -

International audience. Background Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, there has been no randomized, internally and concurrently controlled trial of a shorter, all-oral regimen comprising these newer and repurposed drugs sufficiently powered to produce results for pre-XDR TB patients. Methods endTB-Q is a phase III, multi-country, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of a treatment strategy for patients with pre-XDR TB. Study participants are randomized 2:1 to experimental or control arms, respectively. The experimental arm contains bedaquiline, linezolid, clofazimine, and delamanid. The control comprises the contemporaneous WHO standard of care for pre-XDR TB. Experimental arm duration is determined by a composite of smear microscopy and chest radiographic imaging at baseline and re-evaluated at 6 months using sputum culture results: participants with less extensive disease receive 6 months and participants with more extensive disease receive 9 months of treatment.

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