Table 1.
Baseline Patient Characteristics (Microbiological Modified Intent-to-Treat Population)
| Characteristic | Ceftazidime- Avibactam (n = 393) | Doripenem (n = 417) |
|---|---|---|
| Age, y, mean (SD) | 51.4 (20.2) | 53.3 (18.6) |
| Male | 121 (30.8) | 124 (29.7) |
| Race | ||
| White | 321 (81.7) | 351 (84.2) |
| Black or African American | 1 (0.3) | 4 (1.0) |
| Asian | 35 (8.9) | 28 (6.7) |
| American Indian or Alaska Native | 1 (0.3) | 3 (0.7) |
| Other | 35 (8.9) | 31 (7.4) |
| Body mass index, kg/m2, mean (SD) | 26.2 (5.9) | 26.3 (5.6) |
| Diagnosis | ||
| cUTI without pyelonephritis | 106 (27.0) | 121 (29.0) |
| Pyelonephritis | 287 (73.0) | 296 (71.0) |
| With ≥1 complicating factor | 41 (10.4) | 39 (9.4) |
| Meeting symptom criteria for cUTI | 33 (8.4) | 31 (7.4) |
| Bacteremia | 38 (9.7) | 33 (7.9) |
| Fever | 157 (39.9) | 150 (36.0) |
| White blood cell count, 109/mL, median (range) | 8.5 (3.3–27.8) | 7.9 (3.1–35.4) |
| CrCl, mL/min, mean (SD)a | 87.6 (34.5) | 85.9 (34.5) |
| Renal status | ||
| Normal renal function/mild impairment (CrCl >50 mL/min) | 350 (89.1) | 379 (90.9) |
| Moderate impairment (CrCl 31–50 mL/min) | 42 (10.7) | 35 (8.4) |
| Severe impairment (CrCl <31 mL/min) | 1 (0.3) | 3 (0.7) |
| Baseline pathogen in urineb | ||
| Enterobacteriaceae | 376 (95.7) | 396 (95.0) |
| Escherichia coli | 292 (74.3) | 306 (73.4) |
| Klebsiella pneumoniae | 44 (11.2) | 56 (13.4) |
| Proteus mirabilis | 17 (4.3) | 13 (3.1) |
| Enterobacter cloacae | 11 (2.8) | 13 (3.1) |
| ESBL-positive Enterobacteriaceae | 73 (18.6) | 82 (19.7) |
| Other gram-negative bacteria | 18 (4.6) | 21 (5.0) |
| Pseudomonas aeruginosa | 18 (4.6) | 20 (4.8) |
| Prior systemic antibiotic use | 28 (7.1) | 27 (6.5) |
Data are presented as No. (%) unless otherwise indicated.
Abbreviations: CrCl, creatinine clearance; cUTI, complicated urinary tract infection; ESBL, extended-spectrum β-lactamase; SD, standard deviation.
a As reported by the site using the Cockcroft-Gault method based on local laboratory data.
b Includes pathogens reported with a combined frequency of ≥10 patients. Patients could have >1 pathogen. Multiple isolates of the same species from the same patient are counted only once. Other pathogens isolated in <10 patients were Citrobacter freundii complex (n = 6 overall), Citrobacter koseri (n = 2), Enterobacter aerogenes (n = 2), Klebsiella oxytoca (n = 7), Morganella morganii (n = 4), Serratia marcescens (n = 3), Proteus vulgaris group (n = 2), Providencia rettgeri (n = 2), and Burkholderia cepacia complex (n = 1).