Table 1.
Univariate analysis for baseline characteristics, comorbidities, types of infections, and treatment strategy in patients who received tigecycline inside and outside critical care, and those with SOFA score <7 and ≥7 inside critical care during the study period (N = 153 patients).
| Clinical characteristics and treatment strategy | Total (N = 153) | Critically ill (n = 47) | Non-critically ill (n = 106) | P | Critically ill with SOFA < 7 (n = 17) | Critically ill with SOFA ≥7 (n = 30) | P |
|---|---|---|---|---|---|---|---|
| AGE (YEARS) | |||||||
| <45 | 35 (22.9%) | 12 (25.5%) | 23 (21.7%) | 0.09 | 7 (41.2%) | 5 (16.7%) | 0.02 |
| >45 and ≤ 65 | 37 (24.2%) | 6 (12.8%) | 31 (29.2%) | 4 (23.5%) | 2 (6.7%) | ||
| >65 | 81 (52.9%) | 29 (61.7%) | 52 (49.1%) | 6 (35.3%) | 23 (76.7%) | ||
| GENDER | |||||||
| Male | 79 (51.6%) | 23 (48.9%) | 56 (52.8%) | 0.66 | 6 (35.3%) | 17 (56.7%) | 0.16 |
| Female | 74 (48.4%) | 24 (51.1%) | 50 (47.2%) | 11 (64.7%) | 13 (43.3%) | ||
| COMORBIDITIES AND RISK FACTORS | |||||||
| Cardiovascular Disease | 90 (58.8%) | 36 (76.6%) | 54 (50.9%) | 0.003 | 10 (58.8%) | 26 (86.7%) | 0.03 |
| Diabetes | 46 (30.1%) | 19 (40.4%) | 27 (25.5%) | 0.06 | 5 (29.4%) | 14 (46.7%) | 0.25 |
| COPD | 21 (13.7%) | 10 (21.3%) | 11 (10.4%) | 0.07 | 4 (23.5%) | 6 (20.0%) | 0.78 |
| ARF | 35 (22.9%) | 12 (25.5%) | 23 (21.7%) | 0.60 | 1 (5.9%) | 11 (36.7%) | 0.02 |
| CKD | 19 (12.4%) | 7 (14.9%) | 12 (11.3%) | 0.54 | 1 (5.9%) | 6 (20.0%) | 0.19 |
| CHD | 6 (3.9%) | 0 (0.0%) | 6 (5.7%) | 0.10 | 0 (0.0%) | 0 (0.0%) | NA |
| Hemodynamic Failure | 22 (14.4%) | 7 (14.9%) | 15 (14.2%) | 0.90 | 1 (5.9%) | 6 (20.0%) | 0.19 |
| Vasopressors given before or ≤ 24 h of tigecycline therapy | 37 (24.2%) | 18 (38.3%) | 19 (17.9%) | 0.01 | 2 (11.8%) | 16 (53.3%) | 0.005 |
| Mechanical ventilation | 35 (22.9%) | 17 (36.2%) | 18 (17.0%) | 0.01 | 4 (23.5%) | 13 (43.3%) | 0.17 |
| Neutropenia (<500 mm3) | 30 (19.6%) | 2 (4.3%) | 28 (26.4%) | 0.001 | 0 (0.0%) | 2 (6.7%) | 0.28 |
| MALIGNANCY | |||||||
| No cancer | 103 (67.3%) | 45 (95.7%) | 58 (54.7%) | <0.0001 | 17 (100.0%) | 28 (93.3%) | 0.55 |
| Leukemia | 24 (15.7%) | 1 (2.1%) | 23 (21.7%) | 0 (0.0%) | 1 (3.3%) | ||
| Lymphoma | 11 (7.2%) | 0 (0.0%) | 11 (10.4%) | 0 (0.0%) | 0 (0.0%) | ||
| Solid Tumor | 15 (9.8%) | 1 (2.1%) | 14 (13.2%) | 0 (0.0%) | 1 (3.3%) | ||
| HSCT | |||||||
| No | 139 (90.8%) | 47 (100.0%) | 92 (86.8%) | 17 (100.0%) | 30 (100.0%) | NA | |
| Autologous | 4 (2.6%) | 0 (0.0%) | 4 (3.8%) | 0.03 | 0 (0.0%) | 0 (0.0%) | |
| Allogeneic | 10 (6.5%) | 0 (0.0%) | 10 (9.4%) | 0 (0.0%) | 0 (0.0%) | ||
| DURATION OF TIGECYCLINE THERAPY | |||||||
| 72 h–10 days | 98 (64.1%) | 31 (66.0%) | 67 (63.2%) | 0.76 | 11 (64.7%) | 20 (66.7%) | 0.92 |
| ≥11–14 days | 28 (18.3%) | 7 (14.9%) | 21 (19.8%) | 3 (17.6%) | 4 (13.3%) | ||
| ≥15 days | 27 (17.6%) | 9 (19.1%) | 18 (17.0%) | 3 (17.6%) | 6 (20%) | ||
| INDICATIONS FOR TIGECYCLINE THERAPY | |||||||
| FDA approved Indications | 29 (19.0%) | 6 (12.8%) | 23 (21.7%) | 0.19 | 6 (35.3%) | 0 (0.0%) | <0.0001 |
| cSSTI | 18 (11.8%) | 2 (4.3%) | 16 (15.1%) | 0.055 | 2 (11.8%) | 0 (0.0%) | 0.055 |
| cIAI | 4 (2.6%) | 0 (0.0%) | 4 (3.8%) | 0.18 | 0 (0.0%) | 0 (0.0%) | NA |
| CAP | 8 (5.2%) | 4 (8.5%) | 4 (3.8%) | 0.22 | 4 (23.5%) | 0 (0.0%) | 0.005 |
| Off-label Indications | 124 (81.0%) | 41 (87.2%) | 83 (78.3%) | 0.19 | 11 (64.7%) | 30 (100.0%) | <0.0001 |
| HAP | 30 (19.6%) | 11 (23.4%) | 19 (17.9%) | 0.43 | 2 (11.8%) | 9 (30.0%) | 0.16 |
| VAP | 39 (25.5%) | 24 (51.1%) | 15 (14.2%) | <0.0001 | 8 (47.1%) | 16 (53.3%) | 0.68 |
| Bacteremia | 16 (10.5%) | 7 (14.9%) | 9 (8.5%) | 0.23 | 3 (17.6%) | 4 (13.3%) | 0.69 |
| Sepsis | 14 (9.2%) | 2 (4.3%) | 12 (11.3%) | 0.16 | 0 (0.0%) | 2 (6.7%) | 0.28 |
| Diabetic Ulcer | 8 (5.2%) | 2 (4.3%) | 6 (5.7%) | 0.72 | 1 (5.9%) | 1 (3.3%) | 0.68 |
| UTI | 6 (3.9%) | 1 (2.1%) | 5 (4.7%) | 0.45 | 0 (0.0%) | 1 (3.3%) | 0.45 |
| FN | 24 (15.7%) | 1 (2.1%) | 23 (21.7%) | 0.002 | 0 (0.0%) | 1 (3.3%) | 0.45 |
| TREATMENT STRATEGY | |||||||
| Empiric | 67 (43.8%) | 15 (31.9%) | 52 (49.1%) | 0.049 | 5 (29.4%) | 10 (33.3%) | 0.78 |
| Targeted | 86 (56.2%) | 32 (68.1%) | 54 (50.9%) | 12 (70.6%) | 20 (66.7%) | ||
| Monotherapy | 17 (11.1%) | 4 (8.5%) | 13 (12.3%) | 0.50 | 1 (5.9%) | 3 (10.0%) | 0.63 |
| Combination therapy | 136 (88.9%) | 43 (91.5%) | 93 (87.7%) | 16 (94.1%) | 27 (90.0%) | ||
| TGC+3GC | 3 (2.0%) | 0 (0.0%) | 3 (2.8%) | 0.24 | 0 (0.0%) | 0 (0.0%) | NA |
| TGC+4GC | 23 (15.0%) | 5 (10.6%) | 18 (17.0%) | 0.31 | 3 (17.6%) | 2 (6.7%) | 0.24 |
| TGC+TZP | 38 (24.8%) | 16 (34.0%) | 22 (20.8%) | 0.08 | 7 (41.2%) | 9 (30.0%) | 0.44 |
| TGC+CAR | 71 (46.4%) | 27 (57.4%) | 44 (41.5%) | 0.07 | 8 (47.1%) | 19 (63.3%) | 0.28 |
| TGC+CST | 47 (30.7%) | 16 (34.0%) | 31 (29.2%) | 0.55 | 6 (35.3%) | 10 (33.3%) | 0.89 |
| TGC+AMG | 29 (19.0%) | 3 (6.4%) | 26 (24.5%) | 0.01 | 3 (17.6%) | 0 (0.0%) | 0.02 |
| TGC+TZP+CST | 12 (7.8%) | 4 (8.5%) | 8 (7.5%) | 0.84 | 1 (5.9%) | 3 (10.0%) | 0.63 |
| TGC+CAR+CST | 26 (17.0%) | 10 (21.3%) | 16 (15.1%) | 0.35 | 4 (23.5%) | 6 (20.0%) | 0.78 |
| TGC+AMG+CST | 11 (7.2%) | 3 (6.4%) | 8 (7.5%) | 0.80 | 3 (17.6%) | 0 (0.0%) | 0.02 |
| TGC+CAR+AMG | 10 (6.5%) | 1 (2.1%) | 9 (8.5%) | 0.14 | 1 (5.9%) | 0 (0.0%) | 0.18 |
| TGC+TZP+AMG | 7 (4.6%) | 0 (0.0%) | 7 (6.6%) | 0.07 | 0 (0.0%) | 0 (0.0%) | NA |
| TGC+VAN | 23 (15.0%) | 5 (10.6%) | 18 (17.0%) | 0.31 | 2 (11.8%) | 3 (10.0%) | 0.85 |
| TGC+TEC | 27 (17.6%) | 5 (10.6%) | 22 (20.8%) | 0.13 | 3 (17.6%) | 2 (6.7%) | 0.24 |
AMG, Aminoglycoside; ARI, Acute Renal Injury; CAP, Community Acquired Pneumonia; CAR, Carbapenem; CHD, Chronic Hepatic disease; cIAI, complicated Intra-abdominal Infection; CKD, Chronic Kidney Disease; COPD, Chronic Obstructive Pulmonary Disease; cSSTI, complicated Skin and Soft Tissue Infection; CST, Colistin; d, days; FDA, Food and Drug Administration; FN, Febrile Neutropenia; HAP, Hospital Acquired Pneumonia; HSCT, Hematopoietic Stem Cell Transplantation; NA, Not Applicable; SOFA, Sequential Organ Failure Assessment; TEC, Teicoplanin; TGC, Tigecycline; TZP, Piperacillin/Tazobactam; UTI, Urinary Tract Infection; VAN, Vancomycin; VAP, Ventilator Associated Pneumonia; 3GC, Third Generation Cephalosporin; 4GC, Fourth Generation Cephalosporin.
N.B. Calculation of clinical and microbiological success and failure rates for all categories is done as such:
1-Clinical success rate (%) = Number of patients with clinical success/(Number of patients with clinical success + Number of patients with clinical failure) × 100.
2-Microbiological success rate (%) = Number of patients with microbiological success / (Number of patients with microbiological success + Number of patients with microbiological failure) × 100.