|
Clinical cure rates at test-of-cure visit |
|||||||
| Tigecycline |
Imipenem/cilastatin |
Difference Tigecycline-Imipenem/cilastatin |
Test for Noninferiority |
Test for Differences |
|||
|
|
|||||||
| Population |
N |
% (95% CI) |
N |
% (95% CI) |
% (95% CI) |
P value |
|
|
|
|||||||
| CE |
282/341 |
82.7 (78.3, 86.6) |
295/351 |
84.0 (79.8, 87.7) |
-1 (-7.2, 4.5) |
<0.0001 |
0.70 |
| Overall |
-1 (-6.9, 4.2)* |
||||||
| c-mITT |
303/408 |
74.3 (69.7, 78.4) |
317/399 |
79.4 (75.1, 83.3) |
-5 (-11.2, 0.0) |
<0.0001 |
0.00 |
| Overall |
-5 (-11.0, 0.0) |
||||||
| ME |
199/247 |
80.6 (75.1, 85.3) |
210/255 |
82.4 (77.1, 86.8) |
-1.8 (-9.0, 5.4) |
0.0001 |
0.6892 |
| Monomicrobial |
80/89 |
89.9 (81.7, 95.3) |
92/104 |
88.5 (80.7, 93.9) |
1.4 (-8.7, 11.0) |
||
| Polymicrobial |
119/158 |
75.3 (67.8, 81.8) |
118/151 |
78.1 (70.7, 84.5) |
-2.8 (-12.6, 7.1) |
||
| Overall |
-1.7 (-8.4, 5.1)* |
||||||
| m-mITT |
227/309 |
73.5 (68.2, 78.3) |
244/312 |
78.2 (73.2, 82.7) |
-4.7 (-11.8, 2.3) |
0.0019 |
0.1976 |
| Monomicrobial |
96/121 |
79.3 (71.0, 86.2) |
109/128 |
85.2 (77.8, 90.8) |
-5.8 (-15.9, 4.3) |
||
| Polymicrobial |
131/188 |
69.7 (62.6, 76.2) |
135/184 |
73.4 (66.4, 79.6) |
-3.7 (-13.1, 5.9) |
||
| Overall |
-4.3 (-11.0, 2.5)* |
||||||
|
*Adjusted difference and its 95%CI are calculated from a generalized linear model with a binomial probability function and an identity link. | |||||||
Oliva et al. BMC Infectious Diseases 2005 5:88 doi:10.1186/1471-2334-5-88 |
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