| Clinical success at day 14 (N = 152) | Clinical failure at day 14 (N = 549) | P value |
---|---|---|---|
Age (Mean ± SD), year | 62.79 (18.514) | 66.08 (16.975) | 0.038 |
Gender (female) | 68 (44.7%) | 184 (33.5%) | 0.011 |
Country | Â | Â | 0.001 |
 Israel | 113 (74.3%) | 431 (78.5%) |  |
 Greece | 32 (21.1%) | 60 (10.9%) |  |
 Italy | 7 (4.6%) | 58 (10.6%) |  |
Hematological malignancy | 2 (1.3%) | 37 (6.7%) | 0.010 |
Congenative heart failure | 25 (16.4%) | 133 (24.2%) | 0.042 |
Arterial line | 35 (23%) | 192 (35%) | 0.005 |
Chronic pulmonary disease | 23 (15.1%) | 125 (22.8%) | 0.041 |
Systolic blood pressure, mm Hg (SD) | 111.97 (20.539) | 106.66 (22.499) | 0.009 |
Haemodynamic support | 16 (10.6%) | 127 (23.7%) | 0.000 |
Mechanical ventilation (invasive) | 81 (53.6%) | 381 (70.6%) | 0.000 |
Haemodialysis | 1 (0.7%) | 37 (6.9%) | 0.003 |
Creatinine clearance (Cockcroft-Gault Equation), mL/min (Percentiles 25–75) | 72.60 (41.16–132.14) | 64.01 (36.08–118.69) | 0.199 |
Albumin, g/dL (SD) | 2.46 (0.678) | 2.327 (0.6383) | 0.035 |
Nasogastric tube | 92 (60.5%) | 394 (71.8%) | 0.008 |
Pathogen | |||
 Acinetobacter baumannii | 100 (65.8%) | 448 (81.6%) | 0.000 |
 Enterobacteriacaeae | 35 (23%) | 73 (13.3%) | 0.003 |
 Pseudomonas/other | 17 (11.1%) | 28 (5.1%) | 0.007 |
Type of infection | |||
 Bacteraemia | 68 (44.7%) | 214 (39%) | 0.200 |
 Ventilator-associated or hospital-acquired pneumonia | 55 (36.2%) | 267 (48.6%) | 0.006 |
 Probable ventilator-associated pneumonia | 10 (6.6%) | 29 (5.3%) | 0.537 |
 Urinary tract infection | 19 (12.5%) | 39 (7.1%) | 0.033 |
Acquisition of infection in the intensive care unit | 24 (15.6%) | 167 (30.4%) | 0.000 |
Exclusion from the RCT | 53 (34.9%) | 242 (44.1%) | 0.042 |
Colistin MIC distribution > 0.5 mg/L | 27 (21.3%), n = 127 | 76 (16.7%), n = 456 | 0.230 |
Antibiotic treatment | |||
 Combination arm: colistin and meropenem | 68 (50.7%), n = 134 | 193 (44.1%), n = 438 | 0.174 |
 No loading dose | 12 (9.0%), n = 134 | 62 (14.2%), n = 438 | 0.117 |
 Treatment days in patients alive ≥14 days, median (Percentiles 25–75) | 13 (8–16) | 8 (4–14) | 0.000 |
 Mean colistin maintenance dose per day, million units (Percentiles 25–75) | 7.9 (5.0–9.0) | 7.2 (4.0–9.0) | 0.330 |