PREV-HAP
Trial question
What is the role of interferon gamma-1b in critically ill patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 109
109 patients (37 female, 72 male).
Inclusion criteria: critically ill adult patients, with ≥ 1 acute organ failure, under mechanical ventilation.
Key exclusion criteria: pregnancy; hypersensitivity to interferon gamma-1b; pre-existing immunosuppression; severe hepatic insufficiency; liver cytolysis; chronic renal failure; persisting coma after resuscitated cardiac arrest.
Interventions
N=55 interferon gamma-1b (at a dose of 100 mcg every 48 hours from day 1-9).
N=54 placebo (matching placebo every 48 hours from day 1-9).
Primary outcome
Hospital-acquired pneumonia or death at day 28
47.3%
30.2%
47.3 %
35.5 %
23.6 %
11.8 %
0.0 %
Interferon
gamma-1b
Placebo
No significant
difference ↔
No significant difference in hospital-acquired pneumonia or death at day 28 (47.3% vs. 30.2%; HR 1.76, 95% CI 0.94 to 3.29).
Secondary outcomes
No significant difference in all-cause mortality at day 28 (12.7% vs. 17%; HR 0.68, 95% CI 0.25 to 1.85).
No significant difference in hospital-acquired pneumonia at day 28 (34.5% vs. 15.1%; HR 2.06, 95% CI 0.92 to 4.57).
No significant difference in ARDS at day 28 (12.2% vs. 4.3%; OR 2.72, 95% CI 0.33 to 22.41).
Safety outcomes
No significant differences in serious adverse events, biological pancreatitis.
Conclusion
In critically ill adult patients, with ≥ 1 acute organ failure, under mechanical ventilation, interferon gamma-1b was not superior to placebo with respect to a hospital-acquired pneumonia or death at day 28.
Reference
Antoine Roquilly, Bruno Francois, Olivier Huet et al. Interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a phase 2, placebo-controlled randomized clinical trial. Intensive Care Med. 2023 May;49(5):530-544.
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