Drug Susceptible Pulmonary TuberculosisPhase 2NCT07517445
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
A Phase 2 study testing Bedaquiline, pretomanid, linezolid and Nicotinamide (NAM) in people with Drug Susceptible Pulmonary Tuberculosis, run by Gates Medical Research Institute at 4 sites in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Susceptible Pulmonary Tuberculosis
- What is being tested?
- Bedaquiline, pretomanid, linezolid and Nicotinamide (NAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 17 Apr 2026to 14 Jun 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- ≥1+ AFB smear OR positive Xpert semi-quantitative result
- Molecular confirmation of M. tuberculosis
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- 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
Who cannot join
- Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days
- Extrapulmonary TB (except non-significant pleural/lymph node disease)
- Clinically significant comorbidities or substance abuse impacting safety/compliance
- Pregnant or breastfeeding
- HIV-positive AND any of the following:
- Not on ART or on ART <3 months
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- CD4 <200 cells/µL
- Viral load >200 copies/mL
- AIDS-defining illness (other than pulmonary TB)
- Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)
- Clinically significant ECG abnormality
- Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
TASK Clinical Research Centre
Cape Town, Western Cape, 7530
UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, 7700
Wits RHI - Shandukani Research
Johannesburg, Gauteng, 2001
The Aurum Institute Clinical Research Site - Pretoria
Pretoria, Gauteng, 87
About this study
Official title: 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
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.
- Conditions
- Drug Susceptible Pulmonary Tuberculosis
- Being tested
- Bedaquiline, pretomanid, linezolid, Nicotinamide (NAM)
- Keywords
- Nicotinamide, bedaquiline, pretomanid, linezolid, drug-susceptible pulmonary tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedaquiline, pretomanid, linezolidDrug
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
Bedaquiline, pretomanid, linezolidDrug
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, linezolidDrug
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
Also called Nicotinamide also abbreviated as NAM and also known as niacinamide .
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
| Study group | Role | What they receive |
|---|---|---|
| BPAL/NAM1500 | Experimental | Nicotinamide, bedaquiline, pretomanid, linezolid Receives: Drug: Bedaquiline, pretomanid, linezolid; Dietary Supplement: Nicotinamide (NAM) |
| BPAL/NAM2500 | Experimental | Nicotinamide, bedaquiline, pretomanid, linezolid Receives: Drug: Bedaquiline, pretomanid, linezolid; Dietary Supplement: Nicotinamide (NAM) |
| BPAL | Active comparator | Bedaquiline, pretomanid, linezolid Receives: Drug: Bedaquiline, pretomanid, linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From randomization through Day 64 (EOT)
Safety: SAEs
Proportion of participants with this event
Measured: From randomization through Day 64 (EOT)
Safety: TEAEs
Proportion of participants with this event
Measured: From randomization through Day 64 (EOT)
Safety: AESIs
Proportion of participants with this event
Measured: From randomization through Day 64 (EOT)
Safety: TEAEs leading to treatment discontinuation
Proportion of participants with this event
Measured: From randomization through Day 64 (EOT)
Safety: TEAEs leading to NAM dose reduction
Proportion of participants with this event
Measured: From randomization through Day 64 (EOT)
Secondary outcomes (3)
Bactericidal Activity
Time to Sputum culture conversion to negative of Mtb in MGIT sputum culture.
Measured: 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.
Measured: 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).
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start17 Apr 2026
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Susceptible Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- IQVIA RDS Inc.
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517445
- Sponsor's protocol ID
- Gates MRI TBD15-201
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07517445
- Acronym / sponsor ID
- Gates MRI TBD15-201
- Conditions
- Drug Susceptible Pulmonary Tuberculosis
- Keywords
- Nicotinamide, bedaquiline, pretomanid, linezolid, drug-susceptible pulmonary tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 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.
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Collaborators
- IQVIA RDS Inc.
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPAL/NAM1500 | Experimental | Drug: Bedaquiline, pretomanid, linezolid, Dietary Supplement: Nicotinamide (NAM)Nicotinamide, bedaquiline, pretomanid, linezolid |
| BPAL/NAM2500 | Experimental | Drug: Bedaquiline, pretomanid, linezolid, Dietary Supplement: Nicotinamide (NAM)Nicotinamide, bedaquiline, pretomanid, linezolid |
| BPAL | Active comparator | Drug: Bedaquiline, pretomanid, linezolidBedaquiline, pretomanid, linezolid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (12 listed)
- Prior TB within 3 years, >1 prior episode, or anti-TB treatment within 60 days
- Extrapulmonary TB (except non-significant pleural/lymph node disease)
- Clinically significant comorbidities or substance abuse impacting safety/compliance
- Pregnant or breastfeeding
- HIV-positive AND any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedaquiline, pretomanid, linezolidGroup 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 | Drug | BPAL/NAM1500 |
| Bedaquiline, pretomanid, linezolidGroup 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 | Drug | BPAL/NAM2500 |
| Bedaquiline, pretomanid, linezolidGroup 3 (active control; approximately 55 participants): Combination of bedaquiline (200 mg QD), pretomanid (200 mg QD), and linezolid (600 mg QD), 56 days | Drug | BPAL |
| Nicotinamide (NAM)Also: Nicotinamide also abbreviated as NAM and also known as niacinamide .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 | Dietary supplement | BPAL/NAM1500, BPAL/NAM2500 |
Primary outcome
Bactericidal Activity
Time frame: From randomization through Day 64 (EOT)
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)
Safety: SAEs
Time frame: From randomization through Day 64 (EOT)
Proportion of participants with this event
Safety: TEAEs
Time frame: From randomization through Day 64 (EOT)
Proportion of participants with this event
Safety: AESIs
Time frame: From randomization through Day 64 (EOT)
Proportion of participants with this event
Safety: TEAEs leading to treatment discontinuation
Time frame: From randomization through Day 64 (EOT)
Proportion of participants with this event
Safety: TEAEs leading to NAM dose reduction
Time frame: From randomization through Day 64 (EOT)
Proportion of participants with this event
3 secondary outcomes
Bactericidal Activity
Time frame: Randomization through Day 64 (EOT)
Bactericidal activity
Time frame: Randomization through Day 56 (EOTx)
Evaluate the PK of NAM when administered with BPaL in Group 1 and 2
Time frame: Day 1 and Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gates MRI study director
Gates Medical Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bedaquiline, pretomanid, linezolid and Nicotinamide (NAM) in people with Drug Susceptible Pulmonary Tuberculosis, run by Gates Medical Research Institute at 4 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bactericidal Activity (time frame: From randomization through Day 64 (EOT)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.