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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
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Inclusion criteria
Exclusion criteria
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.
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:
Primary purpose
Allocation
Interventional model
Masking
352 participants in 4 patient groups
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Central trial contact
Mr Don L Mudzengi; Professor Robert Wallis
Data sourced from clinicaltrials.gov
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