Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Summary

endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB) with fluoroquinolone resistance.

Timeline

Start

2020-04-06

Primary completion

2024-10-04

Completion

2024-12-31

Publications

• Guglielmetti L, Khan U, Velasquez GE, Gouillou M, Ali MH, Amjad S, Kamal F, Abubakirov A, Ardizzoni E, Baudin E, Bektassov S, Berry C, Bonnet M, Chavan V, Coutisson S, Dakenova Z, de Jong BC, Dinh LV, Ferlazzo G, Kirakosyan O, Lachenal N, Lecca L, McIlleron H, Mikanda KK, Mucching-Toscano S, Mulders W, Mushtaque H, Nahid P, Nguyen DV, Nguyen NV, Oyewusi L, Motta I, Panda S, Patil S, Pham TH, Phan DT, Phan HTT, Phillips PPJ, Ruiz J, Rupasinghe P, Salahuddin N, Sanchez-Garavito E, Seung KJ, Asfaw MT, Vargas Vasquez D, Rich ML, Varaine F, Mitnick CD; endTB-Q Clinical Trial Team. Bedaquiline, delamanid, linezolid, and clofazimine for rifampicin-resistant and fluoroquinolone-resistant tuberculosis (endTB-Q): an open-label, multicentre, stratified, non-inferiority, randomised, controlled, phase 3 trial. Lancet Respir Med. 2025 Sep;13(9):809-820. doi: 10.1016/S2213-2600(25)00194-8. Epub 2025 Jul 16.
• Patil SB, 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 BC, Delifer C, Demaisons S, Do JM, Dos Santos Tozzi D, Ducher V, Ferlazzo G, Gouillou M, Khan U, Kunda M, Lachenal N, LaHood AN, Lecca L, Mazmanian M, McIlleron H, Moreau M, Moschioni M, Nahid P, Osso E, Oyewusi L, Panda S, Paquet A, Thuong Huu P, Pichon L, Rich ML, Rupasinghe P, Salahuddin N, Sanchez Garavito E, Seung KJ, Velasquez GE, Vallet M, Varaine F, Yuya-Septoh FJ, Mitnick CD, Guglielmetti L. 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. Trials. 2023 Nov 30;24(1):773. doi: 10.1186/s13063-023-07701-6.

Drugs

Indications