6/29/23, 1:41 AM PREV-HAP Pathway Feedback Search Clinical Topics Home Studies PREV HAP 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 N = 109 66.0% male 109 patients (37 female, 72 male) Inclusion criteria: critically ill adults, 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 g 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 % 47.3 35.5 % 30.2 23.6 % 11.8 % https://web.pathway.md/studies/recG2oLFu02lTln0b 1/2 6/29/23, 1:41 AM PREV-HAP Pathway No significant difference 0.0 % Interferon gamma-1b Placebo 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 death from all causes 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 adults, 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 Apr 18;1-15. Open reference URL https://web.pathway.md/studies/recG2oLFu02lTln0b 2/2