Details

Autor(en) / Beteiligte

• Tweed, C D
• Wills, G H
• Crook, A M
• Amukoye, E
• Balanag, V
• Ban, A Y L
• Bateson, A L C
• Betteridge, M C
• Brumskine, W
• Caoili, J
• Chaisson, R E
• Cevik, M
• Conradie, F
• Dawson, R
• Del Parigi, A
• Diacon, A
• Everitt, D E
• Fabiane, S M
• Hunt, R
• Ismail, A I
• Lalloo, U
• Lombard, L
• Louw, C
• Malahleha, M
• McHugh, T D
• Mendel, C M
• Mhimbira, F
• Moodliar, R N
• Nduba, V
• Nunn, A J
• Sabi, I
• Sebe, M A
• Selepe, R A P
• Staples, S
• Swindells, S
• van Niekerk, C H
• Variava, E
• Spigelman, M
• Gillespie, S H

Titel

A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

Ist Teil von

• The international journal of tuberculosis and lung disease, 2021-04, Vol.25 (4), p.305-314

Ort / Verlag

France

Erscheinungsjahr

2021

Quelle

MEDLINE

Beschreibungen/Notizen

• Treatment for TB is lengthy and toxic, and new regimens are needed. 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 (6Pa MZ) or 4 months (4Pa MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa MZ); 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. 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 6Pa MZ, 4Pa MZ, 4Pa MZ 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 6Pa MZ 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. PaMZ regimens did not achieve non-inferiority in this under-powered trial. An ongoing evaluation of PMD remains a priority.