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A Pan-TB Regimen Targeting Host and Microbe (panTB-HM)

T

The Aurum Institute NPC

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Tuberculosis

Treatments

Drug: Pretomanid
Combination Product: Rifafour
Drug: Bedaquiline
Drug: Sutezolid
Drug: N-acetyl cysteine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05686356
AUR1-1-312
RIA2019AMR-2647 (Other Grant/Funding Number)
24206
6986 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

352 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Aged 18 to 65 years
  2. Willing and able to provide signed written consent prior to undertaking any trial-related procedures, or, in the case of illiteracy, witnessed oral consent
  3. Body weight (in light clothing without shoes) between 30 and 90 kg.
  4. Radiographic evidence of pulmonary tuberculosis
  5. Positive Xpert TB/RIF (original or Ultra) for MTB
  6. RIF susceptibility diagnosed by Xpert TB/RIF, with subsequent culture confirmation
  7. If sexually active, willing to use an effective contraceptive method for the duration of tuberculosis treatment
  8. 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
  9. 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
  10. Willing to adhere to a diet excluding tyramine-rich foods (certain mold-ripened cheeses and cured meats), and to avoid eating grapefruits and pomelos

Exclusion criteria

  1. 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

  2. Current or imminent (within 24 hr) treatment for malaria.

  3. Pregnant or nursing

  4. 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.

  5. TB meningitis or spondylitis, or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.

  6. History of allergy or hypersensitivity to any of the trial therapies or related substances.

  7. Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.

  8. Prior TB treatment in the preceding 6 months

  9. Angina pectoris requiring treatment with nitroglycerin or other nitrates

  10. Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator

  11. History of unstable Diabetes Mellitus requiring hospitalization for hyper- or hypo-glycaemia within the past year prior to start of screening.

  12. Use of systemic corticosteroids within the past 28 days.

  13. Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 protease inhibitors

  14. Patients requiring treatment with antidepressants, including MAO inhibitors and SSRIs.

  15. Subjects with any of the following abnormal laboratory values:

    1. HBsAg positive
    2. creatinine >2 mg/dL
    3. hemoglobin <8 g/dL
    4. platelets <100x109 cells/L
    5. serum potassium <3.5 mM/L
    6. alanine aminotransferase (ALT) ≥2.0 x ULN
    7. alkaline phosphatase (AP) >5.0 x ULN
    8. total bilirubin >1.5 mg/dL
    9. random blood glucose >200 mg/dL

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

352 participants in 4 patient groups

Arm 1 (S1200BP)
Experimental group
Description:
Sutezolid 1200mg QD plus bedaquiline and pretomanid for 4 months
Treatment:
Drug: Sutezolid
Drug: Bedaquiline
Drug: Pretomanid
Arm 2 (S1600BP)
Experimental group
Description:
Sutezolid 1600mg QD plus bedaquiline and pretomanid for 4 months
Treatment:
Drug: Sutezolid
Drug: Bedaquiline
Drug: Pretomanid
Arm 3 (S1600BPN)
Experimental group
Description:
Sutezolid 1600mg QD plus bedaquiline pretomanid and N-acetyl cysteine for 4 months
Treatment:
Drug: N-acetyl cysteine
Drug: Sutezolid
Drug: Bedaquiline
Drug: Pretomanid
Arm 4 (HRZE)
Active Comparator group
Description:
Rifafour (2HRZE/4HR)
Treatment:
Combination Product: Rifafour

Trial contacts and locations

8

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Central trial contact

Mr Don L Mudzengi; Professor Robert Wallis

Data sourced from clinicaltrials.gov

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