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).