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 |