Table 2.
Outcomes for intention-to-treat population
| Outcomes | HD group (n = 152) | LD group (n = 159) | RR or HR (95% CI) | RD (95% CI) | p value |
|---|---|---|---|---|---|
| 14-day response, % | 62.5 (95/152) | 59.7 (95/159) | 1.046 (0.876, 1.249) | 2.75 (− 8.08, 13.58) | 0.619 |
| Mortality | |||||
| 14-day mortality, % | 23.7 (36/152) | 27.8 (44/159) | 0.856 (0.585, 1.252) | − 3.99 (− 13.57, 5.74) | 0.421 |
| 28-day mortality,% | 30.9 (47/152) | 37.7 (60/159) | 0.819 (0.601, 1.118) | − 6.81 (− 17.12, 3.73) | 0.206 |
| 72-h mortality, % | 9.9 (15/152) | 9.4 (15/159) | 1.046 (0.530, 2.066) | 0.43 (− 6.13, 7.00) | 0.897 |
| Disposition at day 28 | |||||
| Dead, % | 30.9 (47/152) | 37.7 (60/159) | 0.819 (0.601,1.118) | − 6.81 (− 17.12, 3.73) | 0.250 |
| Alive, still in the ICU, % | 25 (38/152) | 30.2 (48/159) | 0.828 (0.576,1.190) | − 5.19 (− 15.10,4.73) | 0.306 |
| Alive, discharged home, % | 16.4 (25/152) | 9.4 (15/159) | 1.743 (0.956,3.175) | 7.01 (− 0.42,14.45) | 0.065 |
| Alive, palliative care, % | 2.6 (4/152) | 1.9 (3/159) | 1.395 (0.163,3.151) | 0.74 (− 2.56,4.05) | 0.718 |
| Alive, still hospitalized, % | 25 (38/152) | 21.4 (34/159) | 0.872 (0.317,1.721) | 3.62 (− 5.76,13.00) | 0.506 |
| Bacterial clearance* | |||||
| Microbiological cure, % | 35.2 (50/142) | 33.3 (48/144) | 1.056 (0.766, 1.456) | 1.88 (− 9.03, 12.74) | 0.738 |
| Bacterial persistence, % | 56.3 (80/142) | 55.6 (80/144) | 1.014 (0.826, 1.246) | 0.78 (− 10.59, 12.13) | 0.894 |
| Superinfection, % | 11.3 (16/142) | 12.5 (18/144) | 0.901 (0.479, 1.696) | − 1.23 (− 8.89, 6.44) | 0.748 |
| Time-to-event data | |||||
| VFD#, Q2 (Q1, Q3) | 14 (6, 21) | 15 (6, 22) | 1.064 (0.831, 1.362) | Not Applicable | 0.613 |
| ICU-days†, Q2 (Q1, Q3) | 21 (15, 31) | 21 (13, 30) | 0.924 (0.738, 1.158) | Not Applicable | 0.495 |
| Hospital-days‡, Q2 (Q1, Q3) | 30 (19, 42) | 28 (17, 45) | 0.943 (0.752, 1.182) | Not Applicable | 0.611 |
Data are n (%) or median (IQR). n: sample size. HD: high dose. LD: low dose. RR: relative risk. HR: hazard ratio. RD: risk difference. *: Superinfection and original Bacterial persistence co-exist in 6 patients, so the sum of the parts of bacterial clearance is greater than 100% #: Ventilated-free days at 28 days. †: Length of ICU stay. ‡: Length of hospital stay