Colistin + levofloxacin group | Meropenem + levofloxacin group | Risk ratio (95% CI) for the outcome with colistin | p value | |
---|---|---|---|---|
Efficacy | ||||
Primary outcome | ||||
Mortality at 28 days in the mMITT population (n = 157) | 19/82 (23.2) | 19/75 (25.3) | 0.91 (0.53, 1.59) | 0.752 |
Secondary outcomes | ||||
Mortality at 28 days in the MITT population (n = 232) | 27/120 (22.5) | 24/112 (21.4) | 1.05 (0.65, 1.71) | 0.844 |
Mortality at 28 days with CR-GNB (n = 36) | 5/20 (25.0) | 6/16 (35.2) | 0.67 (0.25, 1.79) | 0.425 |
Clinical cure in the MITT population (n = 232) | 82 (68.3) | 81 (72.3) | 0.94 (0.80, 1.12) | 0.507 |
Microbiological cure in the mMITT population (n = 157) | 46 (56.1) | 42 (56.0) | 1.00 (0.76, 1.32) | 0.990 |
Microbiological failure in the mMITT population (n = 157) | 33 (40.2) | 31 (41.3) | 0.97 (0.67, 1.42) | 0.899 |
Microbiological relapse in the mMITT population (n = 157) | 3 (3.7) | 2 (2.7) | 1.37 (0.24, 7.99) | 0.723 |
Safety | ||||
Serious adverse events (n = 232) | 50 (41.7) | 45 (40.2) | 1.04 (0.76–1.41) | 0.818 |
Serious adverse events* (n = 232) | 4 (3.3) | 1 (0.9) | 3.70 (0.42, 32.90) | 0.201 |
CrCl (ml/h) at the end of the treatment day (n = 231) | 90.9 [57.2–141.9] | 122.3 [86.1–185.7] | −37.93 (− 62.96, − 12.90) | 0.003 |
Renal replacement therapy (n = 232) | 11 (9.1) | 2 (1.7) | 5.13 (1.16, 22.65) | 0.015 |
RIFLE score at the end of treatment compared with randomization (n = 232)μ | n = 120 | n = 112 | – | 0.034¥ |
None | 80 (66.7) | 91 (81.3) | – | – |
Risk | 21 (17.5) | 11 (9.8) | – | – |
Injury | 15 (12.5) | 5 (4.5) | – | – |
Failure | 4 (3.3) | 5 (4.5) | – | – |