Table 1.
Demographics and baseline characteristics (mITT)
| 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) |
APACHE-II Acute Physiology and Chronic Health Evaluation-II, BMI body mass index, CLSI Clinical and Laboratory Standards Institute, CPIS Clinical Pulmonary Infection Score, CRP C-reactive protein, MDR multidrug-resistant, mITT modified intent-to-treat population, PCR CT polymerase chain reaction cycle threshold, PDR pan-drug-resistant, SD standard deviation, SOFA Sequential Organ Failure Assessment, XDR extensively drug resistant. †Preventive ventilator-associated pneumonia measures (bundles) were elevation of the head of the bed, daily sedation vacations and extubation readiness assessment, peptic ulcer disease prophylaxis, deep vein thrombosis prophylaxis, and daily oral care with chlorhexidine
*n = 15; †n = 82; ‡n = 82; §n = 179; ¶n = 180 #n = 81; **n = 177; ††n = 82; ‡‡minimum inhibitory concentrations were determined by CLSI broth microdilution at a centralised laboratory; §§MDR, PDR, and XDR as defined by;[29] ¶¶subjects with PA-positive culture results but missing minimum inhibitory concentration records; ##all randomised subjects were positive for PA by PCR within 36 h before randomisation, but not all had positive cultures; ***n = 83; †††n = 81; ‡‡‡n = 99; §§§n = 12; ¶¶¶n = 77; ###n = 74; ****n = 89; ††††n = 76; ‡‡‡‡n = 92