Table 2.
Clinical response at test of cure in the clinically evaluable (primary-outcome), clinical modified intention to treat (secondary-outcome), and microbiologically evaluable (secondary-outcome) populationsa
| Parameter | Tigecycline (75 mg) | Tigecycline (100 mg) | Imipenem/cilastatin |
|---|---|---|---|
| CE population | |||
| Subjects, n | 23 | 20 | 24 |
| Cure, n (%) | 16 (69.6) | 17 (85.0) | 18 (75.0) |
| Differenceb (70% CI) | −5.4 (−21.6, 10.9) | 10.0 (−6.1, 24.8) | N/A |
| c-mITT population | |||
| Subjects, n | 36 | 35 | 34 |
| Cure, n (%) | 19 (52.8) | 25 (71.4) | 18 (52.9) |
| Differenceb (70% CI) | −0.2 (−14.3, 14.0) | 18.5 (4.3, 31.8) | N/A |
| ME population | |||
| Subjects, n | 13 | 10 | 15 |
| Cure, n (%) | 9 (69.2) | 8 (80.0) | 12 (80.0) |
| Differenceb (70% CI) | −10.8 (−32.0, 10.9) | 0.0 (−23.8, 20.9) | N/A |
a
CE, clinically evaluable; CI, confidence interval; c-mITT, clinical modified intention to treat; ME, microbiologically evaluable; N/A, not applicable.
b
Tigecycline versus imipenem/cilastatin.