Table 2.
Placebo (n = 47) | Meropenem (n = 44) | % Difference (95% CIs) | Odds ratio (95% CI s) | p value | |
---|---|---|---|---|---|
Primary endpoint: early worsening, n (%) | 19 (40.4) | 7 (15.9) | 24∙5 (5.9 to 40.8) | 0.28 (0.10 to 0.76) | 0.011 |
Secondary endpoints | |||||
At least 2-point SOFA increase the first 24 h, n (%) | 10 (21.3) | 2 (4.5) | 16∙7 (2.7 to 30.8) | 0.18 (0.04 to 0.86) | 0.028 |
Early worsening per quartile of the admission SOFA score, n/patients at the respective quartile (%) | |||||
SOFA = 0-1 points | 5/15 (33.3) | 0/6 (0) | 33.3 (− 0.09 to 0.58) | * | 0.262 |
SOFA = 2–3 points | 6/10 (60.0) | 7/20 (35.0) | 25.0 (− 0.11 to 53.7) | 0.255 | |
SOFA = 4 points | 5/12 (41.7) | 0/8 (0) | 41.7 (2.2 to 68.1) | * | 0.055 |
SOFA > 4 points | 3/10 (30∙0) | 0/10 (0) | 30.0 (− 7.7 to 60.3) | * | 0.211 |
Resolution of infection, n (%) | 29 (61.7) | 37 (84.1) | 22.4 (4.0 to 38.7) | 3∙28 (1.21 to 8.91) | 0.020 |
Time to infection resolution, days, median (Q1-Q3) | 13.0 (9 to 60) | 12 (8 to 15.8) | NA | NA | 0.018 |
7-day mortality, n (%) | 2 (4.3) | 0 (0) | 4.3 (− 4.3 to 14.3) | * | 0.494 |
28-day mortality, n (%) | 8 (17∙0) | 4 (9.1) | 7∙9 (− 6.6 to 22.2) | 0.49 (0.14 to 1.75) | 0.357 |
60-day mortality, n (%) | 11 (23.4) | 8 (18.2) | 5.2 (− 11.7 to 21.5) | 0.73 (0.26 to 2.02) | 0.611 |
90-day mortality, n (%) | 15 (31.9) | 9 (20.5) | 11.5 (− 6.7 to 28.5) | 0.55 (0.21 to 1.43) | 0.242 |
New infections the first 7 days, n (%) | 4 (8.5) | 3 (6.8) | 1.7 (− 10.8 to 13.9) | 0.79 (0.17 to 3.73) | 1.000 |
New infections the first 60 days, n (%) | 18 (38.3) | 14 (30.2) | 6.5 (− 12.8 to 25.0) | 0.69 (0.29 to 2.68) | 0.507 |
Change of antibiotics, n (%) | 24 (51.1) | 18 (40.9) | 10.2 (− 10 to 29.2) | 0.66 (0.29 to 1.52) | 0.402 |
Duration of hospitalization, days, median (range) | 8 (5 to 14) | 11 (6.3 to 17) | NA | NA | 0.372 |
*Cannot be calculated because one value is zero
n Number of patients, SD standard deviation, SOFA Sequential Organ Failure