MEDI3902 500 mg (N = 16) | MEDI3902 1500 mg (N = 85) | Placebo (N = 83) | Total (N = 184) | |
---|---|---|---|---|
Age, years; mean (SD) | 62.7 (9.3) | 60.3 (15.2) | 64.1 (12.9) | 62.2 (13.8) |
Age < 65 years; n (%) | 7 (43.8) | 42 (49.4) | 39 (47.0) | 88 (47.8) |
Sex, male; n (%) | 10 (62.5) | 54 (63.5) | 62 (74.7) | 126 (68.5) |
Race, n (%) | ||||
Asian | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (0.5) |
Black or African American | 0 (0.0) | 2 (2.4) | 4 (4.8) | 6 (3.3) |
Native Hawaiian or Other Pacific Islander | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (0.5) |
White | 16 (100.0) | 81 (95.3) | 75 (90.4) | 172 (93.5) |
Other | 0 (0.0) | 2 (2.4) | 2 (2.4) | 4 (2.2) |
Weight, kg; mean (SD) | 82.5 (25.2) | 78.8 (19.5) | 84.4 (21.0) | 81.6 (20.7) |
Height, cm; mean (SD) | 167.9 (10.0) | 169.1 (9.6) | 171.1 (10.0) | 169.9 (9.8) |
BMI, kg/m2; mean (SD) | 29.5 (9.4) | 27.5 (6.4) | 29.0 (7.7) | 28.4 (7.3) |
BMI ≤ 30 kg/m2; n (%) | 11 (68.8) | 60 (70.6) | 54 (65.1) | 125 (67.9) |
Clinical severity scores at baseline; mean (SD) | ||||
APACHE-II | 16.9 (2.9)* | 15.3 (5.4)† | 15.5 (5.2)‡ | 15.5 (5.1)§ |
SOFA | 4.5 (2.4)* | 4.4 (2.7)† | 4.0 (2.1) | 4.2 (2.4)¶ |
CPIS | 3.5 (1.5)* | 3.0 (1.5)# | 3.2 (1.5)# | 3.1 (1.5)** |
Duration of mechanical ventilation; days, mean (SD) | 19.5 (15.5) | 25.2 (27.6) | 31.1 (28.4)†† | – |
Previous PA infections ≤ 3 months before randomisation; n (%) | ||||
Yes | 7 (43.8) | 25 (29.4) | 31 (37.8) | 63 (34.4) |
No | 9 (56.3) | 60 (70.6) | 51 (62.2) | 120 (65.6) |
Missing | 0 | 0 | 1 | 1 |
Use of antibiotics in the 3 months before randomisation; n (%) | ||||
Yes | 14 (93.3) | 59 (74.7) | 63 (81.8) | 136 (79.5) |
No | 1 (6.7) | 20 (25.3) | 14 (18.2) | 35 (20.5) |
Missing | 1 | 6 | 6 | 13 |
CLSI susceptibility at baseline;‡‡ n (%) | ||||
Any culture result, n | 16 | 83 | 82 | 181 |
P. aeruginosa positive | 15 (93.8) | 72 (86.7) | 67 (81.7) | 154 (85.1) |
Non-MDR | 6 (37.5) | 37 (44.6) | 25 (30.5) | 68 (37.6) |
MDR§§ | 4 (25.0) | 12 (14.5) | 16 (19.5) | 32 (17.7) |
XDR§§ | 4 (25.0) | 14 (16.9) | 21 (25.6) | 39 (21.5) |
PDR§§ | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Unknown¶¶ | 1 (6.3) | 9 (10.8) | 5 (6.1) | 15 (8.3) |
P. aeruginosa negative## | 1 (6.3) | 11 (13.3) | 15 (18.3) | 27 (14.9) |
MEDI3902 500 mg (N = 16) | MEDI3902 1500 mg (N = 85) | Placebo (N = 83) | MEDI3902 total (N = 101) | |
---|---|---|---|---|
P. aeruginosa PCR CT value; mean (SD) | 28.3 (3.7) | 28.5 (5.7) | 29.2 (6.2) | 28.5 (5.4) |
White blood cell count, 103/μL; mean (SD) | 11.6 (4.4) | 13.2 (6.3) | 11.4 (6.1) | 12.9 (6.1) |
Absolute Neutrophil count, 103/μL; mean (SD) | 9.1 (4.1) | 10.6 (6.0)*** | 8.4 (4.3)††† | 10.4 (5.7)‡‡‡ |
Procalcitonin, μg/L; mean (SD) | 4.8 (15.5)§§§ | 1.0 (2.4)¶¶¶ | 0.61 (1.3)### | 1.5 (6.1)**** |
CRP, mg/dL; mean (SD) | 7.9 (6.3) | 14.7 (37.9)†††† | 15.1 (34.3)¶¶¶ | 13.5 (34.6)‡‡‡‡ |
Ventilator-associated pneumonia prevention† | ||||
All 5 measures used, n (%) | 8 (50) | 36 (42.4) | 31 (37.3) | 44 (43.6) |