Treatment | Total | Delamanid alone | Bedaquiline alone | Both drugs | p-value |
Subjects | 61 | 11 | 39 | 11 | |
Drugs administered, including delamanid and/or bedaquiline n | 5.0 (4.0–6.0) | 5.0 (4.0–6.0) | 5.0 (4.0–6.0) | 5.0 (3.0–6.0) | 0.728 |
Treatment with any injectable drug | 39 (63.9) | 6 (54.5) | 25 (64.1) | 8 (72.7) | 0.688 |
Duration of injectable drug treatment days | 224.0 (188.0–280.0) | 229.0 (168.5–268.3) | 224.0 (198.5–297.5) | 230.0 (166.3–537.3) | 0.863 |
Treatment with any fluoroquinolone | 37 (60.7) | 7 (63.6) | 27 (69.2)¶ | 3 (27.3)¶ | 0.043 |
Treatment with linezolid# | 33 (54.1) | 6 (54.5) | 17 (43.6) | 10 (90.9) | 0.017 |
Treatment with of clofazimine | 12 (19.7) | 1 (9.1) | 5 (12.8)¶ | 6 (54.5)¶ | 0.011 |
Duration of linezolid treatment days | 673.0 (171.0–736.0) | 154.5 (49.0–413.3) | 617.0 (136.0–759.0) | 729.5 (673.0–874.5) | 0.094 |
Duration of delamanid and/or bedaquiline treatment days | 168.0 (166.5–196.5) | 168.0 (167.0–176.0)+ | 168.0 (165.0–182.0)¶ | 341.0 (230.0–375.0)¶,+ | 0.001 |
Combined surgery# | 5 (8.5) | 2 (18.2) | 1 (2.7) | 2 (18.2) | 0.102 |
Culture conversion | 39/55 (70.9) | 8/8 (100) | 24/36 (66.7) | 7/11 (63.6) | 0.160 |
Time to culture conversion days | 119.0 (52.5–198.5) | 122.0 (53.0–145.3)+ | 84.0 (35.5–174.0)¶ | 307.5 (235.0–346.5)¶,+ | <0.001 |
Maximum QTcF ms | 469.0 (447.5–486.5) | 469.0 (444.0–499.0) | 464.0 (448.0–483.0) | 475.0 (464.0–535.0) | 0.386 |
Increase in QTcF from baseline ms | 22.0 (12.0–41.0) | 25.0 (9.0–42.0) | 19.0 (12.0–35.0) | 35.0 (18.0–81.0) | 0.293 |
Significant QTcF prolongation | 42 (68.9) | 7 (63.6) | 26 (66.7) | 9 (81.8) | 0.721 |
Discontinuation of delamanid and/or bedaquiline because of QTcF prolongation | 4 (6.6) | 1 (9.1) | 1 (2.6) | 2 (18.2) | 0.129 |
Data are presented as n, median (interquartile range) or n (%), unless otherwise stated. QTcF: Fridericia's corrected QT interval. Dunn's post hoc test was performed when the result of the Kruskal–Wallis test was significant: #: p>0.05 among groups; ¶: p<0.05 bedaquiline versus both drugs; +: p<0.05 delamanid versus both drugs.