Innovative ongoing trials for an “all-oral” treatment of multidrug-resistant (MDR)/extensively drug-resistant (XDR) tuberculosis (TB)

Trial number/nameType of TB (MDR/XDR)Study phaseRegimens studiedPromoterDuration of new regimenStatusPatients n
1Nix#XDR3Pretomanid, bedaquiline and linezolidTB Alliance6 monthsOngoing>75
2ZeNixXDR3Pretomanid, bedaquiline and linezolid (linezolid treatment dose and duration are double-blinded)TB Alliance26 weeksEnrolling180 (estimated)
3STREAMMDR3A: local WHO standard
B: clofazimine, ethambutol, moxifloxacin and pyrazinamide (40 weeks) + isoniazid, kanamycin and prothionamide (first 16 weeks)
C: bedaquiline, clofazimine, ethambutol, levofloxacin and pyrazinamide (40 weeks) + isoniazid and prothionamide (first 16 weeks)
D: bedaquiline, clofazimine, levofloxacin and pyrazinamide (28 weeks) + isoniazid and kanamycin (first 8 weeks)
IUATLD36/56 weeksEnrollingCurrently >300
4NeXTMDR3Linezolid, bedaquiline, levofloxacin, pyrazinamide + ethionamide or terizidone or high-dose INHSouth African investigators6–9 monthsNot yet recruiting300 (estimated)
5TB PRACTECALMDR/XDR2–3A: local WHO standard
B: bedaquiline and pretomanid + linezolid, moxifloxacin
C: bedaquiline and pretomanid + linezolid, clofazimine
D: bedaquiline and pretomanid + linezolid
MSF6 monthsEnrollingCurrently >100 (630 estimated)
6End TBMDR3A: bedaquiline, linezolid, moxifloxacin, pyrazinamide
B: bedaquiline, linezolid, clofazimine, levofloxacin, pyrazinamide
C: bedaquiline, delamanid, linezolid, levofloxacin, pyrazinamide
D: delamanid, clofazimine, levofloxacin, linezolid, pyrazinamide
E: delamanid, clofazimine, moxifloxacin, pyrazinamide
F: local WHO standard, including the possible use of bedaquiline or delamanid
MSF and PIH9 monthsEnrollingCurrently >170 (750 estimated)
7SimpliciTBMDR (or single resistance to isoniazid or rifampicin)2Bedaquiline, pretomanid, moxifloxacin, pyrazinamideTB Alliance6 monthsEnrollingCurrently >10 (150 estimated)
8MDR-ENDMDR2Delamanid, linezolid, levofloxacin and pyrazinamide versus local WHO standardSeoul National University Hospital9–12 monthsEnrolling(238 estimated)

IUATLD: International Union Against Tuberculosis and Lung Diseases; MSF: Médecins Sans Frontières; PIH: Partners In Health; WHO: World Health Organization; INH: isoniazid: #: definitive results pending; : information reported only for this number of patients.