Table 7.
Patients With Baseline Bacteremia: Microbiologic Modified Intent-to-Treat Population
| Population/Response |
Sulopenem, n/N (%) |
Ertapenem, n/N (%) |
P Value | Difference, % (95% Confidence Interval) |
|---|---|---|---|---|
| Patients with uropathogen in baseline blood culture | 44 | 43 | .9454 | |
| ȃEscherichia coli | 39 | 39 | ||
| ȃKlebsiella pneumoniae | 1 | 4 | ||
| ȃProteus mirabilis | 2 | 0 | ||
| ȃMorganella morganii | 1 | 0 | ||
| ȃEnterobacter cloacae complex | 1 | 0 | ||
| Same bloodstream uropathogen present in baseline urine culture | ||||
| ȃPresent ≥1000 CFU/mL | 42 (95.5) | 40 (93.0) | ||
| ȃPresent ≥100 000 CFU/mL | 36 (81.8) | 37 (86.0) | ||
| ȃBaseline bloodstream uropathogen not present in screening urine culture | 2 (4.5) | 3 (7.0) | ||
| Time to clearance of bacteremia after first does of study drug | ||||
| ȃMean (standard deviation), h:min | 85:45 (62:53) | 75:40a (55:15) | .5700 | |
| ȃMedian, h:min | 66:15 | 68:46a | ||
| ȃRange, h:min | 17:50–256:00 | 16:45–260:00a | ||
| ȃCleared between day 0 and day5 | 38 | 38 | ||
| ȃCleared between day 5 and day 11 | 6 | 5 | ||
| Overall success at day 5 | 18/44 (40.9) | 16/43 (37.2) | 3.7 (−16.7 to 23.8) | |
| Overall success at test of cure | 25/44 (56.8) | 28/43 (65.1) | −8.3 (−28.1 to 12.2) | |
| ȃQuinolone-resistant | 5/10 (50.0) | 5/8 (62.5) | −12.5 (−52.5 to 2.7) | |
| ȃQuinolone-susceptible | 20/34 (58.8) | 23/35 (65.7) | −6.9 (−29.1 to 15.9) | |
| ȃESBL-negative | 20/36 (55.6) | 24/37 (64.9) | −9.3 (−30.9 to 13.1) | |
| ȃESBL-positive | 5/8 (62.5) | 4/6 (66.7) | −4.2 (−49.4 to 44.9) | |
| Reasons for overall nonresponse | ||||
| ȃUrine culture at the follow-up visit demonstrates ≥103 CFU/mL of the baseline uropathogen; all symptoms had resolved | 15/44 (34.1) | 5/43 (11.6) | ||
| ȃNo resolution or worsening of symptoms of cUTI present at trial entry and/or new cUTI symptoms | 2/44 (4.5) | 2/43 (4.7) | ||
| ȃReceipt of nonstudy antibacterial therapy for cUTI | 1/44 (2.3) | 0 | ||
| ȃUrine culture ≥103 and at least 1 symptom not resolved (both clinical and micro failures) | 0 | 2/43 (4.7) | ||
| ȃDeath due to cUTI | 0 | 0 | ||
Abbreviations: CFU, colony-forming unit; cUTI, complicated urinary tract infection; ESBL, extended-spectrum beta-lactamase.
Excluding 1 patient who cleared bacteremia before first dose of study drug (patient had received single dose of ceftriaxone before first dose of study drug). P value for the number of patients with bacteremia derived using the Cochran-Mantel-Haenszel test. P value for the time to clearance of bacteremia derived using the log-rank test.