Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03896685 | Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q) | PHASE3 | COMPLETED | 323 | — | — | Apr 6, 2020 | Dec 31, 2024 | Feb 10, 2025 | 10 | India, Kazakhstan +4 |
| NCT02754765 | Evaluating Newly Approved Drugs for Multidrug-resistant TB | PHASE3 | COMPLETED | 754 | — | — | Dec 1, 2016 | Jun 1, 2023 | Feb 10, 2025 | 12 | Georgia, India +5 |
Proportion of participants with favorable outcome at Week 73. A participant's outcome will be classified as favorable at Week 73 if the outcome is not classified as unfavorable, and one of the following is true: 1. The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between Week 65 and Week 73; 2. The last culture result (from a sputum sample collected between Week 65 and Week 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; 3. There is no culture result from a sputum sample collected between Week 65 and Week 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable.
Proportion of participants with favorable outcome at week 73. A participant's outcome will be classified as favorable at week 73 if the outcome is not classified as unfavorable, and one of the following is true: * The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between weeks 65 and 73; * The last culture result (from a sputum sample collected between weeks 65 and 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; * There is no culture result from a sputum sample collected between weeks 65 and 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable.
| Arm | Type | Description |
|---|---|---|
| endTB-Q: BeDeCLi 24 or 39 weeks | EXPERIMENTAL | endTB-Q regimen: bedaquiline-delamanid-linezolid-clofazimine (BeDeCLi). Subjects who are randomized to this arm will be assigned to duration of 24 or 39 weeks , according to the participant's extent-of-TB-disease phenotype. Participants may take as long as 32 weeks to complete all doses of a 24-week treatment regimen, and up to 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of the experimental regimens will be oral and weight based. |
| endTB-Q: Control arm | ACTIVE_COMPARATOR | endTB-Q is the control regimen, designed according to latest World Health Organization guidelines. |
| endTB regimen 1 (BeLiMoZ) | EXPERIMENTAL | Subjects who are randomized to this arm will receive treatment for 39 weeks and post-treatment followup for 65 weeks. Participants may take as long as 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of experimental regimens will be oral and weight based. Subjects will undergo a linezoilid dose reduction randomization to either 300mg daily or 600mg three times a week after 16 weeks of treatment or after a linezolid-related AE requiring dose reduction, whichever is earlier. |
| endTB regimen 2 (BeLiCLeZ) | EXPERIMENTAL | Subjects who are randomized to this arm will receive treatment for 39 weeks and post-treatment followup for 65 weeks. Participants may take as long as 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of experimental regimens will be oral and weight based. Subjects will undergo a linezoilid dose reduction randomization to either 300mg daily or 600mg three times a week after 16 weeks of treatment or after a linezolid-related AE requiring dose reduction, whichever is earlier. |
| endTB regimen 3 (BeDeLiLeZ) | EXPERIMENTAL | Subjects who are randomized to this arm will receive treatment for 39 weeks and post-treatment followup for 65 weeks. Participants may take as long as 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of experimental regimens will be oral and weight based. Subjects will undergo a linezoilid dose reduction randomization to either 300mg daily or 600mg three times a week after 16 weeks of treatment or after a linezolid-related AE requiring dose reduction, whichever is earlier. |
| endTB regimen 4 (DeLiCLeZ) | EXPERIMENTAL | Subjects who are randomized to this arm will receive treatment for 39 weeks and post-treatment followup for 65 weeks. Participants may take as long as 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of experimental regimens will be oral and weight based. Subjects will undergo a linezoilid dose reduction randomization to either 300mg daily or 600mg three times a week after 16 weeks of treatment or after a linezolid-related AE requiring dose reduction, whichever is earlier. |
| endTB regimen 5 (DeCMoZ) | EXPERIMENTAL | Subjects who are randomized to this arm will receive treatment for 39 weeks and post-treatment followup for 65 weeks. Participants may take as long as 47 weeks to complete all doses of a 39-week treatment regimen. Dosing of experimental regimens will be oral and weight based. |
| endTB regimen 6 (Control) | ACTIVE_COMPARATOR | endTB regimen 6 is the control regimen. |
| Name | Type | Description |
|---|---|---|
| Bedaquiline 100 MG | DRUG | Bedaquiline: 400 mg QD x 2 weeks, followed by 200 mg 3x/week |
| Delamanid 50 MG Oral Tablet | DRUG | Delamanid: 100 mg BID |
| Clofazimine 100 MG Oral Capsule | DRUG | Clofazimine: 100 mg QD |
| Linezolid 600Mg Tab | DRUG | Linezolid: 600 mg QD up to Week 16, followed by 300 mg QD or 600 mg 3x/week according to a secondary randomization |
| Control arm MDR-TB regimen, designed according to latest WHO guidelines | DRUG | Control arm MDR-TB regimen, designed according to latest WHO guidelines (might include bedaquiline, delamanid, linezolid, clofazimine, or all of these drugs). |
| Bedaquiline | DRUG | - |
| Delamanid | DRUG | - |
| Clofazimine | DRUG | - |
| Levofloxacin | DRUG | - |
| Moxifloxacin | DRUG | - |
| Linezolid | DRUG | - |
| Pyrazinamide | DRUG | - |
| Control arm MDR-TB regimen, consistent with WHO guidelines | DRUG | Control arm MDR-TB regimen, consistent WHO guidelines |
Inclusion Criteria: 1. Has documented pulmonary tuberculosis due to strains of M. tuberculosis resistant to rifampin (RIF) and not susceptible to fluoroquinolones, according to a validated rapid molecular test. Patients with RIF-resistant TB who are unable to tolerate fluoroquinolones (history of s...