AzTrials
AzTrials

TuberculosisPhase 2/3panTB-HMNCT05686356

A Pan-TB Regimen Targeting Host and Microbe

A Phase 2/3 study testing Sutezolid, N-acetyl cysteine and Pretomanid in people with Tuberculosis, run by The Aurum Institute NPC at 8 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tuberculosis
What is being tested?
Sutezolid, N-acetyl cysteine and Pretomanid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
8 sitesin 3 countries
Study dates
28 Jul 2023to Jan 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Aged 18 to 65 years
  • Willing and able to provide signed written consent prior to undertaking any trial-related procedures, or, in the case of illiteracy, witnessed oral consent
  • Body weight (in light clothing without shoes) between 30 and 90 kg.
  • Radiographic evidence of pulmonary tuberculosis
  • Positive Xpert TB/RIF (original or Ultra) for MTB
  • RIF susceptibility diagnosed by Xpert TB/RIF, with subsequent culture confirmation
Show all 10Show fewer
  • If sexually active, willing to use an effective contraceptive method for the duration of tuberculosis treatment
  • HIV-1 seronegative, or if HIV-1 seropositive, CD4 T cell count ≥100/µl and either receiving ART or willing to start ART during study participation
  • SARS-CoV-2 PCR or antigen test negative, or if positive, either fully vaccinated against Covid-19 or with D-dimer <0.8 ug/ml
  • Willing to adhere to a diet excluding tyramine-rich foods (certain mold-ripened cheeses and cured meats), and to avoid eating grapefruits and pomelos

Who cannot join

  • Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
  • Current or imminent (within 24 hr) treatment for malaria.
  • Pregnant or nursing
  • Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow-up period.
  • TB meningitis or spondylitis, or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.
  • History of allergy or hypersensitivity to any of the trial therapies or related substances.
Show all 24Show fewer
  • Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
  • Prior TB treatment in the preceding 6 months
  • Angina pectoris requiring treatment with nitroglycerin or other nitrates
  • Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
  • History of unstable Diabetes Mellitus requiring hospitalization for hyper- or hypo-glycaemia within the past year prior to start of screening.
  • Use of systemic corticosteroids within the past 28 days.
  • Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 protease inhibitors
  • Patients requiring treatment with antidepressants, including MAO inhibitors and SSRIs.
  • Subjects with any of the following abnormal laboratory values:
  • HBsAg positive
  • creatinine >2 mg/dL
  • hemoglobin <8 g/dL
  • platelets <100x109 cells/L
  • serum potassium <3.5 mM/L
  • alanine aminotransferase (ALT) ≥2.0 x ULN
  • alkaline phosphatase (AP) >5.0 x ULN
  • total bilirubin >1.5 mg/dL
  • random blood glucose >200 mg/dL

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

South Africa6 sites

  • Clinical HIV Research Unit

    Durban, Durban, 4015

  • TASK Eden

    George, Western Cape, 6529

  • Clinical HIV Research Unit

    Johannesburg, Gauteng, 2092

  • The Aurum Institute, Gavin J Churchyard Legacy Centre (Klerksdorp Clinical Research Centre)

    Klerksdorp, Klerksdorp, 2571

  • The Aurum Institute, Rustenburg Clinical Research Centre

    Rustenburg, North West Provice, 0299

  • The Aurum Institute: Tembisa Clinical Research Centre

    Tembisa, Gauteng, 1632

Other trials in South Africa

Mozambique1 site

  • Instituto Nacional de Saúde

    Maputo

Other trials in Mozambique

Tanzania1 site

  • NIMR-Mbeya Medical Research Centre

    Mbeya

Other trials in Tanzania

About this study

Official title: A Novel 4-month Pan-TB Regimen Targeting Both Host and Microbe (panTB-HM)

This project will develop the first regimen meeting WHO criteria for a pan-TB indication, ie, not requiring knowledge of RIF susceptibility. The regimen will test sutezolid at 2 dose levels, with the approved anti-TB drugs bedaquiline and pretomanid, in a phase 2c trial. It will also test whether the addition of N-acetylcysteine (NAC), a re-purposed host-directed WHO essential medicine, can protect the lung and liver against oxidative damage, preserve lung function, and accelerate the eradication of MTB infection by replenishing glutathione (GSH).

Conditions
Tuberculosis
Being tested
Sutezolid, N-acetyl cysteine, Pretomanid, Bedaquiline, Rifafour
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SutezolidDrug

    Sutezolid will be given at a dose of 1200mg QD in arm 1 and at a dose of 1600mg QD in arms 2 and 3.

  • N-acetyl cysteineDrug

    Also called NAC

    NAC will be given at a dose of 1800 mg BID in arm 3

  • PretomanidDrug

    Pretomanid will be given at its approved dose

  • BedaquilineDrug

    Bedaquiline will be given at its approved dose

  • RifafourCombination product

    Fixed dose combination tablets for TB treatment will be given at approved doses

Study groups in NCT05686356
Study groupRoleWhat they receive
Arm 1 (S1200BP)ExperimentalSutezolid 1200mg QD plus bedaquiline and pretomanid for 4 months
Receives: Drug: Sutezolid; Drug: Pretomanid; Drug: Bedaquiline
Arm 2 (S1600BP)ExperimentalSutezolid 1600mg QD plus bedaquiline and pretomanid for 4 months
Receives: Drug: Sutezolid; Drug: Pretomanid; Drug: Bedaquiline
Arm 3 (S1600BPN)ExperimentalSutezolid 1600mg QD plus bedaquiline pretomanid and N-acetyl cysteine for 4 months
Receives: Drug: Sutezolid; Drug: N-acetyl cysteine; Drug: Pretomanid; Drug: Bedaquiline
Arm 4 (HRZE)Active comparatorRifafour (2HRZE/4HR)
Receives: Combination Product: Rifafour

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients achieving durable (non-relapsing) cure

    Measured: Assessed after 1 year of post-treatment follow-up

Secondary outcomes (12)

  1. The proportion of subjects with TE ALT increases, graded according to severity

    Measured: From day 1 through 4 weeks post end-of-treatment

  2. The proportion of subjects with TE increases in transaminases and bilirubin meeting Hy's criteria for serious liver injury

    Measured: From day 1 through 4 weeks post end-of-treatment

  3. The proportion of subjects with TE AEs, according to seriousness

    Measured: From day 1 through 4 weeks post end-of-treatment

  4. The number of TE AEs per treatment arm, according to seriousness

    Measured: From day 1 through 4 weeks post end-of-treatment

  5. The proportion of subjects requiring temporary or permanent treatment discontinuation due to safety or tolerability concerns

    Measured: From day 1 through 4 weeks post end-of-treatment

  6. FEV1 and FVC at 1, 2, 6, and 18 months after initiation of treatment

    Measured: 1, 2, 6, and 18 months after initiation of treatment

  7. FEV1 and FVC slope during 6 and 18 months after initiation of treatment

    Measured: 6 and 18 months after initiation of treatment

  8. FEV1/FVC ratio at 1, 2, 6, and 18 months after initiation of treatment

    Measured: 1, 2, 6, and 18 months after initiation of treatment

  9. The proportion of subjects with sputum cultures showing growth of MTB at 1, 2, 3, and 4 months after initiation of treatment

    Measured: 1, 2, 3, and 4 months after initiation of treatment

  10. The hazard ratio for stable culture conversion through the 4th month of treatment

    Measured: through the 4th month of treatment

  11. The proportion of subjects with treatment failure

    Measured: More than 1 specimen showing growth of MTB during the final 6 weeks of treatment

  12. The proportion of subjects with relapse

    Measured: At week 72 for the control arm and at week 64 for the experimental arms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2023
  2. Study start28 Jul 2023
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05686356
Sponsor's protocol ID
AUR1-1-312
Other IDs
24206, 6986, RIA2019AMR-2647
Acronym
panTB-HM
Status last verified
May 2025
First submitted
18 Dec 2022
Last updated
28 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Mudzengi D, Mashatole S, Xiang Q, Adrion C, Glover N, Ngwanto T, Mdluli J, Boniface S, Rassool M, Matome B, Paramo L, Svensson E, Fasanmi A, Angelo S, Moyo M, Marx C, Khosa C, Mokaba L, Mofokeng N, Lalashowi J, Nacy C, Charalambous S, Fumane E, Maphossa V, Beattie T, Brumskine W, Venter C, Mapamba D, Heinrich N, Rajaram S, Kooverjee S, Botha L, Nell M, Easton A, Foraida S, Warren RM, Sabi I, Ntinginya N, Wallis RS; panTB-HM Consortium. panTB-HM: a multi-arm clinical trial of a pan-TB regimen targeting both host and microbe. Trials. 2026 Feb 27;27(1):271. doi: 10.1186/s13063-026-09568-9.

    PubMed 41749341

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sutezolid, N-acetyl cysteine and Pretomanid in people with Tuberculosis, run by The Aurum Institute NPC at 8 sites in 3 countries.

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 10 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Africa, Mozambique, Tanzania. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

The proportion of patients achieving durable (non-relapsing) cure (time frame: Assessed after 1 year of post-treatment follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05686356, which also lists 1 linked publication.

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 28 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in