Table 3.

Ongoing and planned clinical trials of new drugs in new regimens for treating MDR-TB^a

Study name	Study summary	Description	Status	Study investigator (organization)
STREAM I trial	Evaluation of a Standardized treatment regimen of anti-TB drugs for patients with MDR-TB	Comparison of standard WHO MDR-TB regimen with 9-month modified Bangladesh regimen	Open to recruitment	Andrew Nunn, Sarah Meredith (The Union)
STAND trial: PA-824/Mfx/Z (GATB NC-006)	Treatment shortening trial of PA-824/Mfx/Z for 4 or 6 months compared to HRZE for 6 months	Study of PA-824/Mfx/Z for DS-TB; one arm enrolling patients with MDR-TB whose isolates are susceptible to FQ and Z	Expected to begin enrolling Q2 2015	Dan Everitt (TB Alliance)
Bdq/PA-824/Z (GATB NC-005)	8-week SSCC study of Bdq + PA-824 + Z	Study of Bdq/PA-824/Z for DS-TB. One MDR-TB arm adds moxifloxacin to Bdq-PA-824-Z	Now enrolling	TB Alliance
NiX-TB	PA-824, Lzd, and Bdq; single arm for 6 or 9 months duration depending on rate of sputum culture conversion	Salvage regimen for patients with XDR-TB	Enrolling patients in South Africa	Dan Everitt (TB Alliance)
STREAM II trial	STREAM stage II: multicountry clinical trial evaluating the shortened MDR-TB regimen	Comparison of 6- vs 9-month Bdq-containing regimens to WHO and Bangladesh regimens	Expected to being enrolling Q4 2015	Andrew Nunn and Sarah Meredith (The Union)
PRACTECAL	Novel short course, 6-month regimens without injectables; uses new and repurposed drugs	3 regimens with Bdq + PA-824 + Lzd	Protocol finalized Expected start Q3 2015	Dr Bern-Thomas Nyang’wa (MSF)
End TB	9 month: novel short course regimens without injectables; uses new and repurposed drugs	Novel, no injectibles, regimens with 4–5 drugs including Bdq and/or Dlm	Protocol near finalized	Franics Varaine, Carole Mitnik (MSF/PIH/HMS)
NExT Trial	Evaluating new treatment regimen for patients with MDR-TB – a randomized controlled Phase III trial	Open label RCT of a 6–9 month injection-free regimen with Bdq, Lzd, Lfx, ethionamide/high dose H, and Z	Waiting for MCC approval, expected enrollment at five sites in South Africa	Keertan Dheda, Akther Goolam-Mohamed

Notes: Copyright 2015. RESIST-TB. All rights reserved. This material has not been reviewed by Research Excellence to Stop TB Resistance prior to release; therefore RESIST-TB may not be responsible for any errors, omissions or inaccuracies, or for any consequences arising there from, in the content. Reproduced with permission of RESIST-TB.

^aAdapted from the RESIST DR-TB-Clinical Trial Progress Report,⁶³ excluding those which are adding new drugs to the standard WHO recommended regimen.

Abbreviations: Bdq, bedaquiline; Dlm, delamanid; DS, drug senstive; FQ, fluoroquinolone; H, isoniazid; HMS, Harvard Medical School; HRZE, isoniazid, rifampicin, pyrazinamide, ethambutol; Lfx, levofloxacin; Lzd, linezolid; Mfx, moxifloxacin; MDR-TB, multidrug-resistant tuberculosis; MMC, Medicines Control Council; MSF, Médecins Sans Frontières; PIH, Partners in Health; Q2, second quarter of; Q3, third quarter of; SSCC, serial sputum colony counting; TB, tuberculosis; WHO, World Health Organization; Z, pyrazinamide.