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. 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. Trials, 24(1):773, BioMed Central, nov, 2023. ![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 [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper doi abstract bibtex 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. 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. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 324 participants across 2 arms affords at least 80% power to show the non-inferiority, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per-protocol populations. This internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen. ClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023.
@article{Patil2023,
abstract = {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. 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. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 324 participants across 2 arms affords at least 80{\%} power to show the non-inferiority, with a one-sided alpha of 0.025 and a non-inferiority margin of 12{\%}, against the control in both modified intention-to-treat and per-protocol populations. This internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen. ClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023.},
author = {Patil, S B and Tamirat, M and Khazhidinov, K and Ardizzoni, E and Atger, M and Austin, A and Baudin, E and Bekhit, M. and Bektasov, S. and Berikova, E. and Bonnet, M. and Caboclo, R. and Chaudhry, M. and Chavan, V. and Cloez, S. and Coit, J. and Coutisson, S. and Dakenova, Z. and {De Jong}, B. C. and Delifer, C. and Demaisons, S. and Do, J. M. and {Dos Santos Tozzi}, D. and Ducher, V. and Ferlazzo, G. and Gouillou, M. and Khan, U. and Kunda, M. and Lachenal, N. and LaHood, A. N. and Lecca, L. and Mazmanian, M. and McIlleron, H. and Moreau, M. and Moschioni, M. and Nahid, P. and Osso, E. and Oyewusi, L. and Panda, S. and P{\^{a}}quet, A. and {Thuong Huu}, P. and Pichon, L. and Rich, M. L. and Rupasinghe, P. and Salahuddin, N. and {Sanchez Garavito}, E. and Seung, K. J. and Vel{\'{a}}squez, G. E. and Vallet, M. and Varaine, F. and Yuya-Septoh, F. J. and Mitnick, C. D. and Guglielmetti, L.},
doi = {10.1186/S13063-023-07701-6},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Patil et al. - 2023 - Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone.pdf:pdf},
issn = {1745-6215},
journal = {Trials},
keywords = {Biomedicine,Health Sciences,Medicine,Medicine/Public Health,OA,OA{\_}PMC,Statistics for Life Sciences,fund{\_}not{\_}ack,general,protocol},
mendeley-tags = {OA,OA{\_}PMC,fund{\_}not{\_}ack,protocol},
month = {nov},
number = {1},
pages = {773},
pmid = {38037119},
publisher = {BioMed Central},
title = {{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}},
url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07701-6 http://creativecom-mons.org/publicdomain/zero/1.0/},
volume = {24},
year = {2023}
}
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E.","Vallet, M.","Varaine, F.","Yuya-Septoh, F. J.","Mitnick, C. D.","Guglielmetti, L."],"bibdata":{"bibtype":"article","type":"article","abstract":"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. 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. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. 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