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BACKGROUND: Treatment for TB is lengthy and toxic, and new regimens are needed.METHODS: Participants with pulmonary drug-susceptible TB (DS-TB) were randomised to receive: 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ); or standard DS-TB treatment for 6 months. The primary outcome was treatment failure or relapse at 12 months post-randomisation. The non-inferiority margin for between-group differences was 12.0%. Recruitment was paused following three deaths and not resumed.RESULTS: Respectively 4/47 (8.5%), 11/57 (19.3%), 14/52 (26.9%) and 1/53 (1.9%) DS-TB outcomes were unfavourable in patients on 6Pa200MZ, 4Pa200MZ, 4Pa100MZ and controls. There was a 6.6% (95% CI -2.2% to 15.4%) difference per protocol and 9.9% (95%CI -4.1% to 23.9%) modified intention-to-treat difference in unfavourable responses between the control and 6Pa200MZ arms. Grade 3+ adverse events affected 68/203 (33.5%) receiving experimental regimens, and 19/68 (27.9%) on control. Ten of 203 (4.9%) participants on experimental arms and 2/68 (2.9%) controls died.CONCLUSION: PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.

Citation

C D Tweed, G H Wills, A M Crook, E Amukoye, V Balanag, A Y L Ban, A L C Bateson, M C Betteridge, W Brumskine, J Caoili, R E Chaisson, M Cevik, F Conradie, R Dawson, A Del Parigi, A Diacon, D E Everitt, S M Fabiane, R Hunt, A I Ismail, U Lalloo, L Lombard, C Louw, M Malahleha, T D McHugh, C M Mendel, F Mhimbira, R N Moodliar, V Nduba, A J Nunn, I Sabi, M A Sebe, R A P Selepe, S Staples, S Swindells, C H van Niekerk, E Variava, M Spigelman, S H Gillespie. A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease. 2021 Apr 01;25(4):305-314


PMID: 33762075

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