Table 2.
Outcomes
| Interferon-gamma group | Placebo group | Adj. OR (95% CI)a Adj. HR (95% CI)a or Adj. Difference (95% CI) |
|
|---|---|---|---|
| Primary outcome: HAP or all-cause mortality on day 28, n/N (%) | 26/55 (47.3) | 16/53 (30.2) | 1.76 (0.94–3.29) |
| Components of the primary outcome, n/N (%) | |||
| All-cause mortality at day 28, yes | 7/55 (12.7) | 9/53 (17) | 0.68 (0.25–1.85) |
| HAP, yes | 19/55 (34.5) | 8/53 (15.1) | 2.06 (0.92–4.57) |
| Type of HAP, n/N (%) | |||
| HAP | 0 (0) | 0 (0) | |
| Ventilated-HAP | 0 (0) | 1/8 (12.5) | – |
| Ventilator-Associated Pneumonia | 19/19 (100) | 7/8 (87.5) | |
| Time of first HAP episode, days, median (25-75th percentile) | 3 (3–5) | 3 (2.5–6) | – |
| Early HAP (< day 5), n/N (%) | 12/55 (21.8) | 5/53 (9.4) | 2.53 (0.80–8.03) |
| Late HAP (> = 5 days), n/N (%) | 7/55 (12.7) | 3/53 (5.7) | 2.57 (0.61–10.91) |
| Severity of hospital-acquired pneumonia | |||
| PaO2/FiO2 ratio, median (25–75th percentile) | 158 (110–171) | 124 (107–186) | – |
| Complications of HAP, yes, n/N (%) | |||
| Pleurisy | 0/19 (0) | 1/8 (12.5) | – |
| Bacteriemia | 3/19 (15.8) | 0/8 (0) | – |
| Ventilator-associated tracheobronchitis, yes, n/N (%) | 6/55 (10.9) | 18/54 (34) | 0.24 (0.08–0.68) |
| Acute respiratory distress syndrome at day 28, n/N (%) | 6/49 (12.2) | 2/47 (4.3) | 2.72 (0.33–22.41) |
| If yes, time in days, median (25–75th percentile) | 3 (3–5) | 3 (3–3) | – |
| If yes, lowest PaO2/FiO2, median (25–75th percentile) | 87 (77–110) | 105 (73–136) | – |
| Non-respiratory infections yes, n/N (%) | |||
| Urinary tract infection | 11/55 (20) | 12/53 (22.6) | 0.92 (0.32–2.7) |
| Septicemia, catheter-related infections | 6/55 (10.9) | 9/53 (17) | 0.57 (0.18–1.76) |
| Surgical site infection | 1/55 (1.8) | 4/53 (7.5) | 0.25 (0.03–2.37) |
| Invasive candidiasis | 1/55 (1.8) | 0/53 (0) | – |
| Infection, yes, n/N (%) | 37/55 (67.3) | 37/54 (69.8) | 0.89 (0.38–2.1) |
| Time on antimicrobial therapy, days, median survival (25–75th percentile) | 9 (7–12) | 8 (5–9) | 0.83 (0.56–1.24) |
| Antibiotic-free days at day 28, median (25–75th percentile) | 18 (5–15) | 18.(8–22) | 0 (– 4 to 3)b |
| Time on invasive mechanical ventilation, days, median survival (25–75th percentile) | 13 (7–22) | 14 (7–22) | 1.08 (0.7–1.66) |
| Ventilation-free days at day 90, median (25–75th percentile) | 76 (54–83) | 72 (12–83) | 1 (– 1 to 7)b |
| Time on ICU hospitalisation, days, median survival (25–75th percentile) | 18 (15–26) | 22 (14–28) | 0.95 (0.61–1.47) |
| ICU-free days at day 90, median (25–75th percentile) | 72 (28–77) | 66 (7–78) | 0 (– 3 to 8)b |
| Time on hospitalisation, days, median survival (25–75th percentile) | 50 (31–62) | 47 (36–63) | 1.19 (0.76–1.88) |
| Hospital-free days at day 90, median (25–75th percentile) | 40 (0–63) | 38 (0–63) | 0 (– 5 to 9)** |
| All-cause mortality at day 90, yes, n/N (%) | 13/55 (23.6) | 13/52 (25) | 0.88 (0.4 –1.93) |
HAP hospital-acquired pneumonia
aAdjusted on stratification factor (sepsis or not) as a fixed effect and on centers as a random effect
bMedian of difference were estimated with the Hodges-Lehmann approach