| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05007821 | Linezolid Dosing Strategies in Drug-Resistant TB | PHASE2 | COMPLETED | 138 | — | — | Sep 27, 2022 | Jan 13, 2026 | May 1, 2026 | 13 | Botswana, Brazil +5 |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If the 1st MTB-neg liquid culture was at week 26, then conversion was met. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions at week 26 and the Cox proportional hazards regression model hazard ratio were calculated; between-arm differences were tested with the log rank test.
Time of permanent discontinuation of at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request by week 26, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm A participants took linezolid (LZD) once a day for the entire treatment period. * Weeks 1-26: LZD 600 mg once daily (QD) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD |
| Arm B | EXPERIMENTAL | Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm B participants took a higher dose of linezolid (LZD) once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period. * Weeks 1-4: LZD 1200 mg once daily (QD) * Weeks 5-26: LZD 1200 mg three times per week (TIW) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD |
| Name | Type | Description |
|---|---|---|
| Linezolid 600 mg | DRUG | One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26 |
| Linezolid 1200 mg (QD) | DRUG | Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 |
| Linezolid 1200 mg (TIW) | DRUG | Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 |
| Bedaquiline 200 mg | DRUG | Two 100mg tablets taken orally once daily in the morning during weeks 1-8 |
| Bedaquiline 100 mg | DRUG | One 100mg tablet taken orally once daily in the morning during weeks 9-26 |
| Delamanid 300 mg | DRUG | Six 50mg tablets taken orally once daily in the morning during weeks 1-26 |
| Clofazimine 300 mg | DRUG | Three 100mg capsules taken orally once daily in the morning during weeks 1-2 |
| Clofazimine 100 mg | DRUG | One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
Inclusion Criteria: 1. Newly diagnosed pulmonary drug-resistant tuberculosis (DR-TB), with resistance to at least rifampicin or rifampin (which is a drug used in the therapy of tuberculosis) confirmed from a sputum specimen collected within 60 days prior to entry. 2. HIV-1 infection status document...