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Table 3 Univariate analysis for clinical failure at day 14a

From: Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria: relevance to external validity

  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    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
  1. aNumbers apply to all patients in the group unless stated otherwise
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