TABLE 2.
Innovative ongoing trials for an “all-oral” treatment of multidrug-resistant (MDR)/extensively drug-resistant (XDR) tuberculosis (TB)
| Trial number/name | Type of TB (MDR/XDR) | Study phase | Regimens studied | Promoter | Duration of new regimen | Status | Patients n | |
| 1 | Nix# | XDR | 3 | Pretomanid, bedaquiline and linezolid | TB Alliance | 6 months | Ongoing | >75¶ |
| 2 | ZeNix | XDR | 3 | Pretomanid, bedaquiline and linezolid (linezolid treatment dose and duration are double-blinded) | TB Alliance | 26 weeks | Enrolling | 180 (estimated) |
| 3 | STREAM | MDR | 3 | A: 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) |
IUATLD | 36/56 weeks | Enrolling | Currently >300 |
| 4 | NeXT | MDR | 3 | Linezolid, bedaquiline, levofloxacin, pyrazinamide + ethionamide or terizidone or high-dose INH | South African investigators | 6–9 months | Not yet recruiting | 300 (estimated) |
| 5 | TB PRACTECAL | MDR/XDR | 2–3 | A: local WHO standard B: bedaquiline and pretomanid + linezolid, moxifloxacin C: bedaquiline and pretomanid + linezolid, clofazimine D: bedaquiline and pretomanid + linezolid |
MSF | 6 months | Enrolling | Currently >100 (630 estimated) |
| 6 | End TB | MDR | 3 | A: 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 PIH | 9 months | Enrolling | Currently >170 (750 estimated) |
| 7 | SimpliciTB | MDR (or single resistance to isoniazid or rifampicin) | 2 | Bedaquiline, pretomanid, moxifloxacin, pyrazinamide | TB Alliance | 6 months | Enrolling | Currently >10 (150 estimated) |
| 8 | MDR-END | MDR | 2 | Delamanid, linezolid, levofloxacin and pyrazinamide versus local WHO standard | Seoul National University Hospital | 9–12 months | Enrolling | (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.