Table 1.
Baseline Demographics and Clinical Characteristics of 153 Patients Included in the Efficacy Population Analysis
| Variable | n = 153 (%)a |
|---|---|
| Age, median (IQR), y | 69 (48–77) |
| Male sex | 82 (53.6) |
| Community-acquired infection | 10 (6.5) |
| Hospital-acquired infection | 143 (93.5) |
| Ward | |
| Medical | 98 (64) |
| Surgical | 25 (16.4) |
| ICU | 30 (19.6) |
| Charlson comorbidity index, mean ± SD | 4.9 ± 3.6 |
| Underlying diseases | |
| Cardiac disease | 56 (36.6) |
| Neurological disease | 53 (34.6) |
| Chronic renal disease | 51 (33.3) |
| Diabetes mellitus | 42 (27.4) |
| Gastrointestinal disease | 41 (26.7) |
| Solid-organ tumor | 37 (24.1) |
| Solid-organ transplant | 19 (12.4) |
| Hematological malignancy | 20 (13) |
| COPD | 35 (22.8) |
| Liver disease | 22 (14.3) |
| Other predisposing conditionsb | |
| Corticosteroids | 52 (33.9) |
| Other immunosuppressive therapy | 29 (18.9) |
| Chemotherapy | 17 (11.1) |
| Neutropeniac | 15 (9.8) |
| Invasive procedures | |
| Central venous catheter | 76 (49.7) |
| Urinary catheter | 111 (72.5) |
| Previous surgeryb | 58 (37.9) |
| Mechanical ventilation/NIV | 28 (18.3) |
| Percutaneous endoscopic gastrostomy | 2 (1.3) |
| Intermittent hemodialysis | 25 (16.3) |
| CRRT | 18 (11.7) |
| Previous ESBL-E colonizationb | 50 (32.6) |
| Severity of clinical presentation | |
| No sepsis | 52 (33.9) |
| Sepsis | 59 (38.6) |
| Septic shock | 42 (27.5) |
| ICU admission due to ESBL-E infection | 74 (48.3) |
| Type of infection | |
| Nosocomial pneumoniae | 46 (30) |
| ABSSSI | 25 (16.3) |
| cUTI | 34 (22.2) |
| cIAI | 25 (16.3) |
| Bone infection | 5 (3.2) |
| Primary bacteremia | 16 (10.4) |
| Other infectionsd | 2 (1.3) |
| Concomitant ESBL-E bacteremia | 47 (30.7) |
| Life-threatening infection | 91 (59.4) |
| Polymicrobial infection | 31 (20.2) |
| Antibiotics before C/T treatment | |
| Received antibiotics before C/T for current infection | 52 (33.9) |
| No. of antibiotics received, median (range) | 1 (1–3) |
| Days of antibiotic therapy, median (range) | 6 (3–14) |
| C/T treatment | |
| Empiric treatment | 46 (30) |
| Combination therapy | 26 (16.9) |
| Time from infection onset to C/T administration, median (IQR), d | 6 (3–15) |
| Days of treatment, median (range) | 14 (8–25) |
| Extended infusion | 34 (22.2) |
| Continuous infusion | 11 (7.2) |
| Intermittent infusion | 108 (70.6) |
| Standard dosage (or adjusted according to creatinine clearance)f | 115 (75) |
| Off-label dosage | 38 (25) |
| Adequate source control of infection | 47/57 (82.4) |
| Successful clinical outcome | 128 (83.7) |
| 30-d mortality | 15 (9.8) |
Abbreviations: ABSSSI, acute bacterial skin and skin-structure infection; C/T, ceftolozane/tazobactam; cIAI, complicated intra-abdominal infection; COPD, chronic obstructive pulmonary disease; CRRT, continuous renal replacement therapy; cUTI, complicated urinary tract infection; ICU, intensive care unit; ICU, intensive care unit; IQR, interquartile range; NIV, noninvasive ventilation.
aData are presented as No. (%) unless otherwise stated.
bWithin the previous 30 days.
cAbsolute neutrophil count <500/mm3.
dOther infections include central venous catheter–related bacteremia (n = 1) and community-acquired pneumonia (n = 1).
eThirty-two patients with hospital-acquired pneumonia and 14 with ventilator-associated pneumonia.
fSix patients with augmented renal clearance.