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| Name | Class |
|---|---|
| IQVIA RDS Inc. | INDUSTRY |
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The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPAL/NAM1500 | Experimental | Nicotinamide, bedaquiline, pretomanid, linezolid |
|
| BPAL/NAM2500 | Experimental | Nicotinamide, bedaquiline, pretomanid, linezolid |
|
| BPAL | Active Comparator | Bedaquiline, pretomanid, linezolid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline, pretomanid, linezolid | Drug | Group 1 (Approximately 55 participants), Combination of NAM 1500 mg twice daily (BID) with bedaquiline (200 mg once daily [QD]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bactericidal Activity | Proportion of participants with sputum culture conversion SCC to negative for Mtb in MGIT liquid culture by Week 8 (Day 56, End of Treatment [EOTx]), defined as two consecutive Mtb-negative culture results, collected at least 1 day apart (i.e., not collected on the same day), occurring by Week 9 (Day 64) with no subsequent Mtb-positive cultures through Week 9 (Day 64) | From randomization through Day 64 (EOT) |
| Safety: SAEs | Proportion of participants with this event | From randomization through Day 64 (EOT) |
| Safety: TEAEs | Proportion of participants with this event | From randomization through Day 64 (EOT) |
| Safety: AESIs | Proportion of participants with this event | From randomization through Day 64 (EOT) |
| Safety: TEAEs leading to treatment discontinuation | Proportion of participants with this event | From randomization through Day 64 (EOT) |
| Safety: TEAEs leading to NAM dose reduction | Proportion of participants with this event | From randomization through Day 64 (EOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Bactericidal Activity | Time to Sputum culture conversion to negative of Mtb in MGIT sputum culture. | Randomization through Day 64 (EOT) |
| Bactericidal activity | Proportion of participants with Mtb-negative MGIT sputum culture(s) at Week 4 (Day 29) and Week 8 (Day 56, EOTx), where confirmation of negative sputum culture at subsequent study timepoint is not required. |
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Inclusion Criteria:
Age 18-65 years at consent
Body weight 40-100 kg at screening
Written informed consent obtained
Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive
Chest X-ray consistent with TB (Investigator assessment)
Able to spontaneously produce sputum
Contraception requirements met
Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence
Males: contraception or abstinence through 90 days post-dose
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gates MRI | Contact | +857-702-2108 | Clinical.trials@gatesmri.org | |
| Gates MRI | Contact | +1-866-789-5757 | Clinical.trials@gatesmri.org |
| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wits RHI - Shandukani Research | Recruiting | Johannesburg | Gauteng | 2001 | South Africa |
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Within 12 months of study completion date
Anonymized participant-level data may be shared with the external research in accordance with trial participant' written and executed informed consent and applicable local regulations. Qualified research may submit a request along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. Additional restrictions may apply due to contractual obligations or regulatory constraints.
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| Bedaquiline, pretomanid, linezolid | Drug | Group 2 (Approximately 55 participants): Combination of NAM 2500 mg BID with bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
|
| Bedaquiline, pretomanid, linezolid | Drug | Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
|
| Nicotinamide (NAM) | Dietary Supplement | Group 1 (Approximately 55 participants), Combination of NAM 2500 mg twice daily (BID) with bedaquiline (200 mg once daily [QD]), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days |
|
|
| Randomization through Day 56 (EOTx) |
| Evaluate the PK of NAM when administered with BPaL in Group 1 and 2 | Concentrations of NAM and its primary metabolite by measuring specific PK parameters at Day 1 and Day 14 (see protocol). | Day 1 and Day 14 |
| The Aurum Institute Clinical Research Site - Pretoria | Recruiting | Pretoria | Gauteng | 87 | South Africa |
|
| TASK Clinical Research Centre | Recruiting | Cape Town | Western Cape | 7530 | South Africa |
|
| UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation) | Recruiting | Cape Town | Western Cape | 7700 | South Africa |
|
| ID | Term |
|---|---|
| C493870 | bedaquiline |
| C410767 | pretomanid |
| D000069349 | Linezolid |
| D009536 | Niacinamide |
| 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 |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
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