TABLE 4.
Favorable outcomes observed at TOC visits for ESBLE and CIPRE for doripenem and comparators (mMITT analysis)a
| Study(ies) or organism groupb | Doripenem |
Comparatorc |
Diff | 95% CI | ||||
|---|---|---|---|---|---|---|---|---|
| N | n | % | N | n | % | |||
| All studies with comparator | ||||||||
| All Enterobacteriaceae isolates | 852 | 627 | 73.6 | 811 | 597 | 73.6 | −0.0 | −4.4-4.3 |
| ESBLE | 30 | 20 | 66.7 | 39 | 24 | 61.5 | 5.1 | −20.6-30.8 |
| CIPRE | 84 | 52 | 61.9 | 84 | 40 | 47.6 | 14.3 | −1.8-30.4 |
| DORI-05 (complicated urinary tract infection) | ||||||||
| All Enterobacteriaceae isolates | 304 | 226 | 74.3 | 303 | 228 | 75.2 | −0.9 | −8.1-6.3 |
| ESBLE | 6 | 3 | 50.0 | 7 | 1 | 14.3 | 35.7 | −27.4-98.9 |
| CIPRE | 45 | 24 | 53.3 | 42 | 10 | 23.8 | 29.5 | 7.8-51.3 |
| DORI-07 and DORI-08 (complicated intra-abdominal infection) | ||||||||
| All Enterobacteriaceae isolates | 374 | 289 | 77.3 | 330 | 257 | 77.9 | −0.6 | −7.1-5.9 |
| ESBLE | 8 | 6 | 75.0 | 8 | 5 | 62.5 | 12.5 | −45.0-70.0 |
| CIPRE | 18 | 15 | 83.3 | 16 | 13 | 81.3 | 2.1 | −29.6-33.7 |
| DORI-09 (nosocomial pneumonia) | ||||||||
| All Enterobacteriaceae isolates | 60 | 44 | 73.3 | 64 | 42 | 65.6 | 7.7 | −10.0-25.5 |
| ESBLE | 14 | 9 | 64.3 | 21 | 15 | 71.4 | −7.1 | −44.8-30.5 |
| CIPRE | 16 | 10 | 62.5 | 20 | 12 | 60.0 | 2.5 | −35.1-40.1 |
| DORI-10 (nosocomial pneumonia) | ||||||||
| All Enterobacteriaceae isolates | 114 | 68 | 59.6 | 114 | 70 | 61.4 | −1.8 | −15.3-11.8 |
| ESBLE | 2 | 2 | 100.0 | 3 | 3 | 100.0 | 0.0 | −41.7-41.7 |
| CIPRE | 5 | 3 | 60.0 | 6 | 5 | 83.3 | −23.3 | −93.9-47.3 |
N, number of subjects in each treatment group; n, number cured (microbiologically or clinically); Diff, doripenem value minus comparator value; 95% CI, 2-sided 95% confidence interval using the normal approximation to the difference of two binomial proportions with continuity correction.
ESBLE, extended-spectrum β-lactamase-producing Enterobacteriaceae isolates, including isolates of E. coli, Klebsiella spp., and Proteus spp., with ceftazidime MICs of ≥2 μg/ml; CIPRE, Enterobacteriaceae isolates with ciprofloxacin MICs of ≥4 μg/ml.
The comparators were levofloxacin (DORI-05), meropenem (DORI-07 and DORI-08), piperacillin-tazobactam (DORI-09), and imipenem (DORI-10).