A temporary precautionary pause in enrolment into all arms of the trial was implemented on 21 July 2026, due to emerging hepatic safety signal. A protocol amendment is currently underway.
A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis
Sponsor study identifier
interventional
165
1 country
4
Study Start
April 17, 2026
Actual (reported)Primary Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 8, 2026
Actual (reported)April 17, 2026
Actual (reported)June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Bactericidal Activity
Randomization through Day 64 (EOT)
Bactericidal activity
Randomization through Day 56 (EOTx)
Evaluate the PK of NAM when administered with BPaL in Group 1 and 2
Day 1 and Day 14
Nicotinamide, bedaquiline, pretomanid, linezolid
Nicotinamide, bedaquiline, pretomanid, linezolid
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
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Bedaquiline, pretomanid, linezolid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid, linezolid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid, linezolid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordWits RHI - Shandukani Research
Johannesburg, Gauteng, 2001, South Africa
The Aurum Institute Clinical Research Site - Pretoria
Pretoria, Gauteng, 87, South Africa
TASK Clinical Research Centre
Cape Town, Western Cape, 7530, South Africa
UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, 7700, South Africa
Gates MRI
Gates Medical Research Institute
First Submitted
April 1, 2026
First Posted
April 8, 2026
Study Start
April 17, 2026
Actual (reported)Primary Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Bedaquiline, pretomanid, linezolid
Group 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Linked from the registry description. Each source intervention is retained as reported.
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
In: Bedaquiline, pretomanid, linezolid
Contact the study team to confirm eligibility.
Study Completion
June 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 10, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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