TABLE 3.
Treatment responses in patients in mMITT and SmMITT populationsc
| Response and patient group | n/m (%) |
% (90% CI) |
||
|---|---|---|---|---|
| IMI-REL | Colistin plus IMI | Unadjusted difference | Adjusted differencea | |
| Favorable overall response | ||||
| mMITT population | 15/21 (71.4) | 7/10 (70.0) | 1.4 | −7.3 (−27.5 to 21.4) |
| HABP/VABP | 7/8 (87.5) | 2/3 (66.7) | 20.8 | |
| cIAI | 0/2 | 0/2 | 0.0 | |
| cUTI | 8/11 (72.7) | 5/5 (100.0) | −27.3 (−52.8 to 12.8)b | |
| SmMITT population | 21/28 (75.0) | 10/13 (76.9) | −1.9 | −4.5 (−24.2 to 20.7) |
| HABP/VABP | 7/8 (87.5) | 3/4 (75.0) | 12.5 (−25.4 to 56.6)b | |
| cIAI | 2/5 (40.0) | 1/3 (33.3) | 6.7 | |
| cUTI | 12/15 (80.0) | 6/6 (100.0) | −20.0 (−41.4 to 14.2)b | |
| Favorable clinical response (day 28) | ||||
| mMITT population | 15/21 (71.4) | 4/10 (40.0) | 31.4 | 26.3 (1.3 to 51.5) |
| SmMITT population | 21/28 (75.0) | 7/13 (53.8) | 21.2 | 17.6 (−5.9 to 42.5) |
| All-cause mortality (through day 28) | ||||
| mMITT population | 2/21 (9.5) | 3/10 (30.0) | −20.5 | −17.3 (−46.4 to 6.7) |
| SmMITT population | 3/28 (10.7) | 3/13 (23.1) | −12.4 | −10.5 (−35.2 to 9.6) |
Adjusted differences and 90% confidence intervals are based on the values obtained by the Miettinen and Nurminen method (36) stratified by infection site.
The 90% confidence intervals were calculated by the Miettinen and Nurminen method (36).
CI, confidence interval; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HABP, hospital-acquired bacterial pneumonia; IMI, imipenem-cilastatin; mMITT, microbiological modified intent-to-treat; n/m, number of patients with a favorable response or all-cause mortality/number of patients evaluable; REL, relebactam; SmMITT, supplemental microbiological modified intent-to-treat; VABP, ventilator-associated bacterial pneumonia.