Table 1.
Patient Demographics: Primary Analysis Population: Microbiologic Modified Intent-to-Treat
| Parameter | Sulopenem (N = 444), n (%) |
Ertapenem (N = 440), n (%) |
|---|---|---|
| Age, mean (SD), years | 57.4 (18.4) | 59.5 (17.9) |
| Gender | ||
| ȃMale | 174 (39.2) | 189 (43.0) |
| ȃFemale | 270 (60.8) | 251 (57.0) |
| Geographic region | ||
| ȃUnited States | 25 (5.6) | 16 (3.6) |
| ȃNot the United States | 419 (94.4) | 424 (96.4) |
| Race | ||
| ȃBlack or African American | 0 (0.0) | 1 (0.2) |
| ȃAsian | 1 (0.2) | 2 (0.5) |
| ȃWhite | 441 (99.3) | 437 (99.3) |
| ȃNative Hawaiian or Pacific Islander | 1 (0.2) | 0 (0.0) |
| ȃOther | 1 (0.2) | 0 (0.0) |
| Body mass index, kg/m2 | ||
| ȃMean (SD) | 27.4 (6.0) | 27.5 (5.7) |
| Creatinine clearance, mL/mina | ||
| ȃMean (SD) | 73.0 (30.3) | 71.3 (31.5) |
| ȃ>60 | 276 (62.2) | 262 (59.5) |
| ȃ30–60 | 149 (33.6) | 152 (34.5) |
| ȃ<30 | 19 (4.3) | 26 (5.9) |
| Type of infection | ||
| ȃPyelonephritis | 261 (58.8) | 257 (58.4) |
| ȃcUTI | 183 (41.2) | 183 (41.6) |
| cUTI factors | ||
| ȃPresence of an indwelling urethral catheter | 21 (4.7) | 23 (5.2) |
| ȃ>100 mL of residual urine after voiding | 82 (18.5) | 86 (19.5) |
| ȃNeurogenic bladder | 13 (2.9) | 11 (2.5) |
| ȃObstructive uropathy due to nephrolithiasis, tumor, or fibrosis | 50 (11.3) | 38 (8.6) |
| ȃAzotemia | 3 (0.7) | 4 (0.9) |
| ȃUrinary retention in men possibly due to benign prostatic hypertrophy | 68 (15.3) | 80 (18.2) |
| ȃSurgically modified or abnormal urinary tract anatomy | 30 (6.8) | 42 (9.5) |
| Bacteremia | 44 (9.9) | 43 (9.8) |
| Baseline pathogen from urine or blood cultureb | ||
| ȃEscherichia coli | 338/444 (76.1) | 346/440 (78.6) |
| ȃKlebsiella pneumoniae | 56/444 (12.6) | 47/440 (10.7) |
| ȃProteus mirabilis | 26/444 (5.9) | 14/440 (3.2) |
| ȃEnterobacter cloacae complex | 9/444 (2.0) | 15/440 (3.4) |
| ȃKlebsiella oxytoca | 7/444 (1.6) | 7/440 (1.6) |
| ȃOtherc | 28/444 (6.3) | 30/440 (6.8) |
| ESBL-positive Enterobacterales | 110/444 (24.8) | 125/440 (28.4) |
| FQ-nonsusceptible Enterobacterales | 162/444 (36.5) | 179/440 (40.7) |
| TMP-SMX–nonsusceptible Enterobacterales | 154/444 (34.7) | 161/440 (36.6) |
| ESBL-positive/FQ-nonsusceptible | 91/444 (20.5) | 99/440 (22.5) |
| ESBL-positive/FQ-nonsusceptible/TMP-SMX–nonsusceptible | 58/444 (13.1) | 75/440 (17.0) |
Data are presented as number (%) unless otherwise indicated.
Abbreviations: cUTI, complicated urinary tract infection; ESBL, extended-spectrum β-lactamase; FQ, fluoroquinolone; SD, standard deviation; TMP-SMX, trimethoprim-sulfamethoxazole.
As reported by the site using the Cockcroft-Gault method based on local laboratory data.
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 (n = 9 overall), Morganella morganii (n = 9), Klebsiella variicola (n = 6), Serratia marcescens (n = 6), Citrobacter koseri (n = 5), Klebsiella aerogenes (n = 4), Proteus vulgaris (n = 3), Providencia rettgeri (n = 3), Raoultella ornithinolytica (n = 3), Proteus hauseri (n = 2), Providencia stuartii (n = 2), Enterobacter nonspeciated (n = 1), Klebsiella nonspeciated (n = 1), Leclercia adecarboxylata (n = 1), Raoultella planticola (n = 1), Serratia liquefaciens (n = 1), and Serratia nonspeciated (n = 1).