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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
| Pfizer | INDUSTRY |
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The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study also measured the level of LZD and BDQ in the participants' blood.
When the study was designed, there was currently no "standard of care" or single standardized treatment regimen recommended for everyone with drug resistant-tuberculosis (DR-TB). Current DR-TB treatments were not well tolerated and often had side effects. There was a need to identify drugs with enough anti-TB activity (treatment against TB) and good safety profiles that could improve outcomes in the treatment of DR-TB.
The main purpose of this study was to evaluate the efficacy and tolerability of a new shorter course anti-TB treatment regimen that compared two dosing strategies of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). As a secondary aim, the study assessed the safety (the level and type of side effects from a drug or treatment) of the combination of these drugs.
Everyone in the study took BDQ, DLM, and CFZ once a day for the entire treatment period. The difference between the two treatment groups in the study was in how participants took the fourth drug: LZD. Participants in group A took one dose of LZD once a day for the entire treatment period. Participants in group B took a higher dose of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid 600 mg | Drug | One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26 |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to 26 Weeks Stable Culture Conversion in Liquid Media | 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. | Up to 26 weeks |
| Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death | 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. | Up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 a participant did not convert by week 8, 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. |
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Inclusion Criteria:
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.
HIV-1 infection status documented as either absent or present.
For participants living with HIV, either currently on an antiretroviral therapy (ART) regimen or willing and able to start ART within 30 days after entry.
Efavirenz or etravirine (drugs used to treat HIV) must be discontinued prior to a participant's starting anti-TB medications. For participants on efavirenz or etravirine, they must be willing and able to discontinue these at least 7 days prior to initiating study TB medications.
For participants living with HIV, CD4+ cell (a type of white blood cell) count greater than or equal to 50 cells/mm3 obtained within 60 days prior to study entry.
For females of reproductive potential, negative serum or urine pregnancy test.
Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two of the following forms of birth control while receiving TB study medications and for 30 days after stopping study medications:
Appropriate laboratory values as determined by the study doctor obtained within 14 days prior to entry.
Karnofsky performance score (an assessment tool for functional impairment) greater than or equal to 50 within 30 days prior to entry.
Ability and willingness of candidate and/or legal guardian/representative to provide informed consent and meet requirements for the study.
Chest X-ray obtained within 30 days prior to entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constance A. Benson | The University of California, San Diego | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaborone CRS (Site ID: 12701) | Gaborone | South-East District | Botswana | |||
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101) |
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| Label | URL |
|---|---|
| The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.1, July 2017 | View source |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
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Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.
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Participants were enrolled from 27 September 2022 to 04 September 2024 in 13 sites located in South Africa (5 sites), Haiti (2 sites), Thailand (2 sites), Botswana, Brazil, Peru, and Philippines.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | 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.
Linezolid 600 mg: One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: V3.0 Dated 16 JUL 2024 | Jul 16, 2024 |
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A5356 is a phase II, prospective, randomized, two-arm, open-label, multicenter clinical trial to evaluate the anti-tuberculosis (TB) activity, safety, and tolerability of an injectable-free short course regimen for treatment of multidrug-/rifampicin-resistant (MDR-/RR-), pre-extensively drug-resistant (pre-XDR-), and extensively drug-resistant (XDR-) TB comparing two dosing strategies of linezolid (LZD) combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ).
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| Linezolid 1200 mg (QD) | Drug | Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 |
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| 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 |
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| Bedaquiline 200 mg | Drug | Two 100mg tablets taken orally once daily in the morning during weeks 1-8 |
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| Bedaquiline 100 mg | Drug | One 100mg tablet taken orally once daily in the morning during weeks 9-26 |
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| Delamanid 300 mg | Drug | Six 50mg tablets taken orally once daily in the morning during weeks 1-26 |
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| Clofazimine 300 mg | Drug | Three 100mg capsules taken orally once daily in the morning during weeks 1-2 |
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| Clofazimine 100 mg | Drug | One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
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| At week 8 |
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 a participant did not convert by week 16, 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | At week 16 |
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | At week 26 |
| Proportion of Participants Achieving Stable Liquid Culture Conversion | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date. | At week 38 |
| Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death | Time of permanent discontinuation of LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request by week 26, they were censored at the date of permanent discontinuation of LZD 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. | Up to 26 weeks |
| Proportion of Participants With Temporary Discontinuation of LZD For Any Reason | Time of temporary discontinuation of LZD for any reason was the corresponding date of first temporary discontinuation. If a participant did not temporarily discontinue LZD by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with temporary discontinuation of LZD were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | Up to 26 weeks |
| Proportion of Participants With LZD Dose Reduction | Time of LZD dose reduction was the corresponding date of the first LZD dose reduction. If a participant did not undergo a LZD dose reduction by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with LZD dose reduction were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | Up to 26 weeks |
| Proportion of Participants With Treatment-Related Adverse Events | Time of treatment-related adverse event was the corresponding date of the averse event. If a participant did not experience a treatment-related adverse event, 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 treatment-related adverse event were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | Up to 26 weeks |
| Proportion of Participants With Unfavorable TB Treatment Outcome | Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 26, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | At week 26 |
| Proportion of Participants With Unfavorable TB Treatment Outcome | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date. | At week 38 |
| Proportion of Participants With Unfavorable TB Treatment Outcome | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 72 visit will be analyzed after the study completion date. | At week 72 |
| Pharmacokinetic Parameter for Linezolid: Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Linezolid: Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Linezolid: Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Linezolid: Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | At week 4 |
| Pharmacokinetic Parameter for Linezolid: Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | At week 4 |
| Pharmacokinetic Parameter for Delamanid: Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid: Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid: Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid: Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | At week 4 |
| Pharmacokinetic Parameter for Delamanid: Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | At week 4 |
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | At week 4 |
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | At week 4 |
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | At week 4 |
| Number of Participants With >90% Directly Observed Therapy Doses Taken During the Treatment Period | At each visit, the site reported the number of directly observed therapy (DOT) doses since the last visit. The number of expected DOT doses was 182. The number of expected DOT doses was adjusted by removing the number of days during temporary holds due to adverse events. This avoided penalizing participants who missed DOT doses due to protocol-required treatment holds for adverse events. Participants who missed DOT doses for other reasons were penalized even if they made up the missed doses by the week 30 study visit as allowed by the protocol. The proportion of expected 182 DOT doses was calculated as the total number of DOT doses reported by the site divided by the adjusted number of expected DOT doses. | Up to 26 weeks |
| Rio de Janeiro |
| 21040-360 |
| Brazil |
| GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site ID: 31730) | Port-au-Prince | HT-6110 | Haiti |
| Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site ID: 30022) | Port-au-Prince | HT-6110 | Haiti |
| Barranco CRS (Site ID: 11301) | Lima | 15063 | Peru |
| De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) (Site ID: 31981) | Cavite | 4114 | Philippines |
| Wits Helen Joseph Hospital CRS (Wits HJH CRS) (Site ID: 11101) | Johannesburg | Gauteng | 2092 | South Africa |
| Durban International CRS (Site ID: 11201) | Durban | KwaZulu-Natal | 4052 | South Africa |
| Rustenburg CRS (Site ID: 31684) | Rustenburg | North West | 0300 | South Africa |
| University of Cape Town Lung Institute (UCTLI) CRS (Site ID: 31792) | Cape Town | Western Cape | 7700 | South Africa |
| South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site ID: 31793) | Cape Town | Western Cape | 7705 | South Africa |
| Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802) | Pathum Wan | Bangkok | 10330 | Thailand |
| Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site ID: 31784) | Chiang Mai | 50200 | Thailand |
| FG001 | Arm B | 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 ctook that higher dose of LZD just three times a week for the rest of the treatment period.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | 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.
Linezolid 600 mg: One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
| BG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| MTB Culture Result | At the screening, entry, and Week 2 visits, 1-2 sputa were collected for 2 cultures (1 liquid medium and 1 solid medium for each sputum) to detect presence of Mycobacterium tuberculosis at baseline. The summary result was MTB-positive if at least 1 culture was MTB-positive. The summary result was MTB-negative if all cultures were either MTB-negative or a mix of MTB-negative and indeterminate. The summary result was indeterminate if all cultures were indeterminate. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time to 26 Weeks Stable Culture Conversion in Liquid Media | 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. | All randomized participants who had at least 1 MTB-positive sputum culture at baseline (based on cultures from Screening, Entry, and Week 2 [excluded N=13]), except those who did not have proof of pulmonary drug-resistant TB [N=2] or were otherwise clinically ineligible for the study (i.e., those with TB drug sensitivity testing results pending at study entry who later showed resistance to one or more study drugs [N=2]). | Posted | Median | Inter-Quartile Range | Weeks | Up to 26 weeks |
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| Primary | Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death | 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. | All participants | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 26 weeks |
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| Secondary | Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 a participant did not convert by week 8, 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All randomized participants who had at least 1 MTB-positive sputum culture at baseline (based on cultures from Screening, Entry, and Week 2 [excluded N=13]), except those who did not have proof of pulmonary drug-resistant TB [N=2] or were otherwise clinically ineligible for the study (i.e., those with TB drug sensitivity testing results pending at study entry who later showed resistance to one or more study drugs [N=2]). | Posted | Number | 95% Confidence Interval | proportion of participants | At week 8 |
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| Secondary | Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 a participant did not convert by week 16, 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All randomized participants who had at least 1 MTB-positive sputum culture at baseline (based on cultures from Screening, Entry, and Week 2 [excluded N=13]), except those who did not have proof of pulmonary drug-resistant TB [N=2] or were otherwise clinically ineligible for the study (i.e., those with TB drug sensitivity testing results pending at study entry who later showed resistance to one or more study drugs [N=2]). | Posted | Number | 95% Confidence Interval | proportion of participants | At week 16 |
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| Secondary | Proportion of Participants Achieving Stable Liquid Culture Conversion | 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 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 of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All randomized participants who had at least 1 MTB-positive sputum culture at baseline (based on cultures from Screening, Entry, and Week 2 [excluded N=13]), except those who did not have proof of pulmonary drug-resistant TB [N=2] or were otherwise clinically ineligible for the study (i.e., those with TB drug sensitivity testing results pending at study entry who later showed resistance to one or more study drugs [N=2]). | Posted | Number | 95% Confidence Interval | proportion of participants | At week 26 |
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| Secondary | Proportion of Participants Achieving Stable Liquid Culture Conversion | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date. | Not Posted | Jan 2027 | At week 38 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death | Time of permanent discontinuation of LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request by week 26, they were censored at the date of permanent discontinuation of LZD 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. | All participants | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 26 weeks |
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| Secondary | Proportion of Participants With Temporary Discontinuation of LZD For Any Reason | Time of temporary discontinuation of LZD for any reason was the corresponding date of first temporary discontinuation. If a participant did not temporarily discontinue LZD by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with temporary discontinuation of LZD were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All participants | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 26 weeks |
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| Secondary | Proportion of Participants With LZD Dose Reduction | Time of LZD dose reduction was the corresponding date of the first LZD dose reduction. If a participant did not undergo a LZD dose reduction by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with LZD dose reduction were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All participants | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 26 weeks |
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| Secondary | Proportion of Participants With Treatment-Related Adverse Events | Time of treatment-related adverse event was the corresponding date of the averse event. If a participant did not experience a treatment-related adverse event, 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 treatment-related adverse event were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All participants | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 26 weeks |
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| Secondary | Proportion of Participants With Unfavorable TB Treatment Outcome | Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 26, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula. | All randomized participants who had at least 1 MTB-positive sputum culture at baseline (based on cultures from Screening, Entry, and Week 2 [excluded N=13]), except those who did not have proof of pulmonary drug-resistant TB [N=2] or were otherwise clinically ineligible for the study (i.e., those with TB drug sensitivity testing results pending at study entry who later showed resistance to one or more study drugs [N=2]). One additional participant was missing the week 26 TB treatment outcome. | Posted | Number | 95% Confidence Interval | proportion of participants | At week 26 |
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| Secondary | Proportion of Participants With Unfavorable TB Treatment Outcome | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date. | Not Posted | Jan 2027 | At week 38 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Unfavorable TB Treatment Outcome | The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 72 visit will be analyzed after the study completion date. | Not Posted | Jan 2027 | At week 72 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter for Linezolid: Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Linezolid: Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Linezolid: Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Linezolid: Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours*ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Linezolid: Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | mL/h | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid: Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid: Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid: Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid: Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours*ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid: Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | mL/h | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Minimum Plasma Concentration (Cmin) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Maximum Plasma Concentration (Cmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Time to Reach Maximum Plasma Concentration (Tmax) | Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Area Under the Concentration-time Curve (AUC) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule. | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | hours*ng/mL | At week 4 |
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| Secondary | Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Apparent Oral Clearance (CL/F) | Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). | First 20 participants in each arm who consented to undergo intensive PK sampling. | Posted | Median | Inter-Quartile Range | mL/h | At week 4 |
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| Secondary | Number of Participants With >90% Directly Observed Therapy Doses Taken During the Treatment Period | At each visit, the site reported the number of directly observed therapy (DOT) doses since the last visit. The number of expected DOT doses was 182. The number of expected DOT doses was adjusted by removing the number of days during temporary holds due to adverse events. This avoided penalizing participants who missed DOT doses due to protocol-required treatment holds for adverse events. Participants who missed DOT doses for other reasons were penalized even if they made up the missed doses by the week 30 study visit as allowed by the protocol. The proportion of expected 182 DOT doses was calculated as the total number of DOT doses reported by the site divided by the adjusted number of expected DOT doses. | All randomized participants who took at least one dose of study drug and had at least one DOT form completed up to Week 26. Two participants had no post-entry DOT data and were excluded | Posted | Count of Participants | Participants | Up to 26 weeks |
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From entry through Week 26
Adverse events (AEs) were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017. An AE is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution (i.e., relationship to treatment). Participants have not completed study follow-up at this time. These tables will be updated once the study database is complete.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | 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.
Linezolid 600 mg: One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 | 0 | 69 | 14 | 69 | 52 | 69 |
| EG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 | 2 | 69 | 18 | 69 | 57 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Normochromic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome associated tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pericarditis tuberculous | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tuberculous pleurisy | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Normochromic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Mucosal discolouration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Aspergilloma | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatitis A antibody positive | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hallucination, tactile | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypnopompic hallucination | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company | (301) 628-3348 | ACTGCT.gov@fstrf.org |
| Nov 6, 2025 |
| Prot_ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol with Letter of Amendment | Sep 13, 2024 | Apr 22, 2026 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2025 | Feb 9, 2026 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D014376 | Tuberculosis |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069349 | Linezolid |
| C493870 | bedaquiline |
| C516022 | OPC-67683 |
| D002991 | Clofazimine |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010619 | Phenazines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| 30 - < 60 |
|
| >= 60 |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Botswana |
|
| Philippines |
|
| Brazil |
|
| South Africa |
|
| Thailand |
|
| Peru |
|
| MTB-Positive |
|
| Indeterminate |
|
A Cox Proportional Hazards regression model was used to test whether there was a statistically significant interaction between treatment and sex. |
| 0.64 |
| Superiority |
| This analysis examined whether a treatment by race interaction existed. | Regression, Cox | A Cox Proportional Hazards regression model was used to test whether there was a statistically significant interaction between treatment and race. | 0.33 | Superiority |
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
|
|
|
|
|
|
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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
|
|
|
|
|
|
|
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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|
|
|
|
|
|
|
|
| Arm B |
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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8
Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26
Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26
Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2
Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26
|
|
| OG001 | Arm B | 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.
Linezolid 1200 mg (QD): Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4 Linezolid 1200 mg (TIW): Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26 Bedaquiline 200 mg: Two 100mg tablets taken orally once daily in the morning during weeks 1-8 Bedaquiline 100 mg: One 100mg tablet taken orally once daily in the morning during weeks 9-26 Delamanid 300 mg: Six 50mg tablets taken orally once daily in the morning during weeks 1-26 Clofazimine 300 mg: Three 100mg capsules taken orally once daily in the morning during weeks 1-2 Clofazimine 100 mg: One 100mg capsule taken orally once daily in the morning during weeks 3-26 |
|
|
|