Interferon gamma-1b for the prevention of hospital-acquired pneumonia in critically ill patients: a phase 2, placebo-controlled randomized clinical trial
Primary result · Hospital-acquired pneumonia or deathResult — go to the resultAdjusted hazard ratio 1.76 95% CI 0.94–3.29- stopped early for potential harm
- Planned sample size 200; stopped after second interim safety analysis for potential harm; follow-up completed June 2022
Authors' conclusion
Among mechanically ventilated patients with acute organ failure, treatment with interferon gamma-1b compared with placebo did not significantly reduce the incidence of hospital-acquired pneumonia or death on day 28.
Study context
- Population
- Critically ill adults with ≥1 acute organ failure under mechanical ventilation, 11 European hospitals108 (99%) completed
- Participants
- 109 adults
- Comparison
- Interferon gamma-1b vs placebo
- Interferon-gamman = 55
- Primary endpoint
- Composite of:
- Hospital-acquired pneumonia
- All-cause mortality
- Follow-up
- Day 28
Methodological detailsmulticenter, placebo-controlled, planned interim safety analyses
- Multicenter
- Placebo-controlled
- Planned interim safety analyses
Primary result
Hospital-acquired pneumonia or death · 28 days
Adjusted hazard ratio
1.76
95% CI 0.94–3.29
P = 0.08
Events by treatment group
Interferon-gamma vs Placebo
aHR 1.76 (95% CI 0.94–3.29); P = 0.08
As reported in the abstract
Further findings
- Hospital-acquired pneumonia developed in a subgroup with decreased CCL17 response to interferon-gamma
- Exploratory analysis
Safety
Serious adverse events
P = 0.19
- Serious adverse events: 24 of 55 vs 17 of 54
Original publication
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. Published 18 April 2023. doi:10.
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