NCT02619994 (MDR-END) |
2/3 |
238 adults, HIV+ and HIV- |
Delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months (depending on time to sputum culture conversion) vs. locally-used WHO-approved MDR-TB regimen (intensive phase regimen consists of four effective second-line antituberculosis drugs, including injectable second-line drugs, and pyrazinamide for at least 20 months) |
Recruiting |
2021 |
NCT02409290 (STREAM stage 2) |
3 |
530 adults and children (≥ 15 years), HIV+ and HIV- |
Moxifloxacin, clofazimine, ethambutol, and pyrazinamide daily for 9 months, with initial isoniazid, kanamycin, and prothionamide daily for 2 months; or bedaquiline, clofazimine, ethambutol, levofloxacin, and pyrazinamide daily for 9 months, with initial isoniazid (high dose) and prothionamide daily for 2 months (all oral); or bedaquiline, clofazimine, levofloxacin, and pyrazinamide daily for 6 months, with initial isoniazid (high dose) and kanamycin for 2 months vs. 20-24-month local regimen |
Recruiting |
2022 |
NCT02754765 (endTB) |
3 |
750 adults and children (≥ 15 years), HIV+ and HIV- |
Bedaquiline, linezolid, moxifloxacin, and pyrazinamide daily for 9 months; or bedaquiline, linezolid, clofazimine, levofloxacin, and pyrazinamide daily for 9 months; or bedaquiline, linezolid, delamanid, levofloxacin, and pyrazinamide daily for 9 months, or delamanid, linezolid, clofazimine, levofloxacin, and pyrazinamide daily for 9 months; or delamanid, clofazimine, moxifloxacin, and pyrazinamide daily for 9 months vs. local regimen |
Recruiting |
2021 |
NCT02589782 (TB PRACTECAL) |
2/3 |
630 adults and children (≥ 15 years), HIV+ and HIV- |
Bedaquiline, pretomanid, moxifloxacin, and linezolid daily for 6 months; or bedaquiline, pretomanid, linezolid, and clofazimine daily for 6 months; or bedaquiline, pretomanid, and linezolid daily for 6 months (all oral) vs. local regimen |
Recruiting |
2021 |
NCT01918397 (Opti-Q) |
2 |
111 adults (> 18 years), HIV+ and HIV- |
Levofloxacin (14, 17, or 20 mg/kg daily) plus optimized background regimen for 6 months vs. levofloxacin (11 mg/kg daily) plus optimized background regimen for 6 months |
Active, not recruiting |
2020 |
NCT02333799 |
3 |
109 adults and children (≥ 14 years), HIV+ and HIV- |
Single arm study: bedaquiline (200 mg daily for 2 weeks, then 200 mg three times weekly), pretomanid (200 mg daily), and linezolid (600 mg twice daily) for 6 months |
Active, not recruiting |
2021 |
NCT02454205 (NEXT) |
2/3 |
154 adults (> 18 years), HIV+ and HIV- |
Bedaquiline, linezolid, levofloxacin, pyrazinamide, and either high-dose isoniazid or ethionamide or terizidone daily (all oral) for 6-9 months vs. conventional treatment (kanamycin, moxifloxacin, pyrazinamide, ethionamide, and terizidone for 21-24 months) |
Active, not recruiting |
2020 |
NCT03141060 |
1/2 |
48 children (<18 years), HIV+ and HIV- |
Single arm study: bedaquiline (100 mg twice daily) plus optimized background regimen for 6 months |
Recruiting |
2021 |
NCT03338621 |
2c/3 |
450 adults, HIV+ and HIV- |
Single arm study: bedaquiline, pretomanid, moxifloxacin, and pyrazinamide for 6 months |
Recruiting |
2022 |
NCT03086486 (ZeNix) |
3 |
180 adults and children (≥ 14 years), HIV+ and HIV- |
Linezolid (600 or 1,200 mg daily, double-blinded), bedaquiline (200 mg daily for 2 weeks, then 100 mg daily), and pretomanid (200 mg daily) for 2 or 6 months |
Recruiting |
2021 |
NCT02354014 |
2 |
60 children (< 18 years), HIV- |
Single arm study: bedaquiline (daily for 2 weeks, then 3 times a week) plus optimized background regimen for 6 months |
Recruiting |
2025 |
NCT02583048 |
2 |
84 adults (> 18 years), HIV+ and HIV- |
Bedaquiline plus optimized background regimen for 6 months; or delamanid plus optimized background regimen for 6 months, or bedaquiline and delamanid plus optimized background regimen for 6 months |
Active, not recruiting |
2021 |
NCT03604848 (GRACE-TB) |
3 |
488 adults (≥ 18 years), HIV- |
Pyrazinamide, amikacin, moxifloxacin, prothionamide, and cycloserine for 9 or 12 months vs. WHO-approved MDR-TB regimen for 24 months |
Not yet recruiting |
2024 |
NCT03867136 (TB-TRUST) |
3 |
354 adults (≥ 18 years), HIV- |
Levofloxacin, linezolid, cycloserine and pyrazinamide(or clofazimine if resistant to pyrazinamide) for 6 to 8 months vs. WHO standardized shorter regimen of 9-11 months |
Not yet recruiting |
2022 |
NCT01859923 |
2 |
37 children (<18 years), HIV+ and HIV- |
Delamanid plus optimized background regimen for 6 months |
Active, not recruiting |
2020 |
NCT03896685 (endTB-Q) |
3 |
324 adults and children (≥ 15 years), HIV+ and HIV- |
BeDeCLi regimen: bedaquiline-delamanid-linezolid-clofazimine for 24 or 39 weeks vs. local regimen according to WHO guidelines |
Not yet recruiting |
2022 |
NCT04062201 (BEAT) |
3 |
400 adults and children (≥ 12 years), HIV+ and HIV- |
Bedaquiline, delamanid, and linezolid plus levofloxacin and clofazimine for 6 months vs. local regimen for 9 months |
Recruiting |
2023 |