ALISTER clinical study:
Participants were recruited at the Royal Infirmary of Edinburgh. Adults (≥16 years, ≤85 years), receiving treatment for active or latent TB, or NTM infection were included. Patients were excluded if they did not have the capacity to provide informed consent or were known to be HIV positive. Full written informed consent was obtained from every participant and the study was approved by the West of Scotland Research Ethics Committee.
Patients were classified as having active TB either if they had culture confirmation of M. tuberculosis and presence of active disease, or if a clinician decided there was sufficient evidence of active disease to start them on treatment. Latent TB patients had a positive interferon-gamma release assay (IGRA) and no evidence of active disease. Patients with NTM infection had grown at least 2 cultures with non-tuberculous mycobacterium and had clinical signs of pulmonary disease (Griffith et al. , 2007; Haworth et al. , 2017).
Active and latent TB patients were treated following WHO guidelines (World Health Organization (WHO), 2017, 2018). Patients with susceptible active TB were treated with isoniazid, rifampicin, ethambutol and pyrazinamide for an initiation phase of 2 months, followed by rifampicin and isoniazid for a continuation phase of 4 months (World Health Organization (WHO), 2017). Patients with latent TB were treated with either a combination of isoniazid and rifampicin for 3 months, or isoniazid or rifampicin alone for 6 months (World Health Organization (WHO), 2018). Patients with M. avium complex (MAC) infection were treated with the recommended regimen of rifampicin, ethambutol and clarithromycin for 2 years (Haworth et al. , 2017). Dependent on the NTM species, disease severity, resistance profile of the infection and tolerance of the individual, drugs were replaced or added, including isoniazid, moxifloxacin, azithromycin and amikacin (Griffith et al. , 2007; Haworth et al. , 2017).