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RESEARCH QUESTION/RATIONALE: Influenza-associated aspergillosis (IAA) was recently found to be a frequent and severe complication of influenza pneumonia in ICU patients. Belgian and Dutch studies indicated that 16%-23% of ICU-patients with influenza developed IAA. Underlying diseases were non-typical, including previously healthy individuals, and the IAA mortality rate was 51% compared with 28% in severe influenza without IAA. Delay of antifungal therapy was significantly associated with mortality.

HYPOTHESIS: Posaconazole prophylaxis prevents IAA in ICU-patients with severe influenza.

STUDY DESIGN: A prospective cluster randomized cross-over trial will be performed in 10 centers in the Netherlands and 4 centers in Belgium.

STUDY POPULATION: Patients admitted to the ICU with proven influenza.

INTERVENTION & COMPARATOR: Patients will receive either posaconazole prophylaxis or standard of care.

OUTCOME MEASURES: Number of (breakthrough) IAA in both arms is primary outcome measure, ICU-mortality is secondary outcome measure.

SAMPLE SIZE/DATA-ANALYSIS: We anticipate 18% IAA cases in the control arm and 6% in the posaconazole prophylaxis arm. 2 groups of 112 patients are required to have a 80% chance of detecting an increase in the primary outcome measure from 82% in the control group to 94% in the prophylaxis group. Including a 40% drop-out rate 378 patients need to enrolled, (8-10 patients per center; 14 centers). The target can be reached within 3 influenza seasons.

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