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Table 1 Characteristics of episodes with or without renal impairment (RI group or non-RI group, respectively)

From: Proposal of initial and maintenance dosing regimens with linezolid for renal impairment patients

  All, 118 episodes in 108 patients RI group, 35 episodes (29.7%) in 33 patients Non-RI group, 83 episodes (70.3%) in 75 patients P-value
Demographics
 Age (years), median (IQR) 71 (58.5–78) 78 (72–82) 67 (47–74) < 0.0001
 Sex (male/female), (%/%) 76/42 (64.4/35.6) 22/13 (62.9/37.1) 54/29 (65.1/34.9) 0.84
 Height (m), median (IQR) 1.61 (1.53–1.67) 1.56 (1.45–1.63) 1.64 (1.56–1.70) 0.0091
 Body weight (kg), median (IQR) 57.1 (48.0–64.2) 49.4 (45.0–60.3) 59.3 (52.2–65.4) 0.0018
 Body mass index (kg/m2), median (IQR) 22.2 (20.1–23.7) 21.0 (18.9–22.9) 22.4 (20.6–24.6) 0.017
Laboratory, median (IQR)
 Serum creatinine (mg/dL) 0.65 (0.50–1.00) 1.20 (0.79–1.49) 0.57 (0.48–0.74) < 0.0001
 CLCRC-G 76.0 (49.2–105.4) 36.2 (26.9–49.4) 93.7 (72.0–118.7) < 0.0001
 Total bilirubin (mg/dL) 0.4 (0.3–0.7) 0.4 (0.3–0.8) 0.4 (0.3–0.6) 0.85
Baseline hematological parameters
 Hemoglobin concentration (g/dL) 9.8 (8.5–11.6) 8.9 (8.3–10.2) 10.1 (8.7–11.9) 0.0081
 Platelet count (×103/μL), median (IQR) 243 (177–319) 208 (151–284) 255 (181–247) 0.062
 Low platelet count at baseline < 150 × 103/μL, n (%) 23 (19.5) 8 (22.9) 15 (18.1) 0.61
 Episodes with platelet transfusion during therapy, n (%) 8 (6.8) 4 (11.4) 4 (4.8) 0.23
 Episodes with DIC, n (%) 15 (12.7) 5 (14.3) 10 (12.1) 0.77
Main reason for linezolid
Type of infection, n (%)
  Skin and soft tissue infections, and surgical site infections 47 (39.8) 9 (25.7) 38 (45.8) 0.063
  Bacteremia 36 (30.5) 18 (51.4) 18 (21.7) 0.0021
  Bone and joint infections 31 (26.3) 12 (34.3) 19 (22.9) 0.25
  Respiratory tract infections 26 (22.0) 8 (22.86) 18 (21.69) 1.00
  Intra-abdominal infections 8 (6.8) 4 (11.4) 4 (4.8) 0.23
  Mediastinitis 7 (5.9) 2 (5.7) 5 (6.0) 1.00
  Central nerve system infections 5 (4.2) 1 (2.9) 4 (4.8) 1.00
  Endocarditis 4 (3.4) 2 (5.7) 2 (2.4) 0.58
  Urinary tract infections 4 (3.4) 3 (8.6) 1 (1.2) 0.078
  Unknown 6 (5.1) 1 (2.9) 5 (6.0) 0.67
Microbiological isolate, n (%)
  MRSA 63 (53.4) 18 (51.4) 45 (54.2) 0.84
  MR-CoNS 25 (21.2) 8 (22.9) 17 (20.5) 0.81
  Enterococci 7 (5.9) 3 (8.6) 4 (4.8) 0.42
  Enterococcus faecalis 2 (1.7) 1 (2.9) 1 (1.2) 0.51
  Enterococcus faecium 5 (4.2) 2 (5.7) 3 (3.6) 0.63
  Corynebacterium species 6 (5.1) 4 (11.4) 2 (2.4) 0.063
  Bacillus cereus 3 (2.5) 2 (5.7) 1 (1.2) 0.21
  Other 8 (6.8) 4 (11.4) 4 (4.8) 0.23
  No isolate, Unknown 11 (9.3) 2 (5.7) 9 (10.8) 0.50
Linezolid dosage and exposure
  Empirical/target therapy, n/n (%/%) 17/101 (14.4/85.6) 2/33 (5.7/94.3) 15/68 (18.1/81.9) 0.093
  Dose (mg/kg/day), median (IQR) 20.7 (17.8–24.2) 23.6 (18.5–26.7) 20.0 (17.3–22.3) 0.017
  Mean Cmin of fixed doses at steady state (mg/L), mean ± SD 17.3 ± 10.5 25.6 ± 10.4 14.1 ± 8.8 < 0.0001
  Number of all TDM instances, median (IQR) 6 (3–8) 6 (4–11) 6 (2–8) 0.33
  Number of TDM instances under steady-state conditions, median (IQR) 3 (2–6) 3 (2–6) 3 (2–6) 0.47
  Episodes with TDM assessment performed during linezolid treatment, until end of treatment 56 (47.5) 21 (60.0) 35 (42.2) 0.11
  Episodes needing dosage adjustments to avoid overexposure, n (%) 42/56 (73.2) 19/21 (90.5) 22/35 (62.9) 0.031
  Duration of linezolid treatment (days), median (IQR) 20 (11–37.5) 16 (11–40) 21 (11–36) 0.96
Co-treatment, n (%)
  Amlodipine 16 (13.6) 7 (20.0) 9 (10.8) 0.24
  Omeprazole 15 (12.7) 4 (11.4) 11 (13.3) 1.00
  Rifampicin 11 (9.3) 5 (14.3) 6 (7.2) 0.30
  Amiodarone 2 (1.7) 1 (2.9) 1 (1.2) 0.51
  Dexamethasone 2 (1.7) 1 (2.9) 1 (1.2) 0.51
Other antimicrobials, n (%)
  Meropenem 26 (22.0) 7 (20.0) 19 (22.9) 0.81
  Doripenem 10 (8.5) 1 (2.9) 9 (10.8) 0.28
  Piperacillin/tazobactam 15 (12.7) 7 (20.0) 8 (9.6) 0.14
  Daptomycin 2 (1.7) 1 (2.9) 1 (1.2) 0.51
  Ciprofloxacin 5 (4.2) 0 (0.0) 5 (6.0) 0.32
  Levofloxacin 7 (5.9) 0 (0.0) 7 (8.4) 0.10
  Micafungin 7 (5.9) 2 (5.7) 5 (6.0) 1.00
  Liposomal amphotericin B 4 (3.4) 2 (5.7) 2 (2.4) 0.58
  Voriconazole 3 (2.5) 0 (0.0) 3 (3.6) 0.55
Type of toxicity, n (%)
  Thrombocytopenia 48 (40.7) 22 (62.9) 26 (31.3) 0.0002
  Median time from initiation of therapy to development of thrombocytopenia (n = 48), median days (IQR) 12.5 (9.0–15.8) 12.5 (10.8–15) 12.5 (2.8–17.3) 0.56
  Severe thrombocytopenia 22 (18.6) 10 (28.6) 12 (14.5) 0.12
  1. Abbreviations: RI renal impairment, CLCRC-G creatinine clearance calculated using the Cockcroft-Gault formula, DIC disseminated intravascular coagulopathy, MRSA methicillin-resistant Staphylococcus aureus, MR-CoNS methicillin-resistant coagulase-negative staphylococci, TDM therapeutic drug monitoring