18 and older, any sex, with Aspergillosis; Pulmonary, Invasive (Etiology). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With IAA-infection at ICU DischargePrimary· from date of admission in ICU assessed up to ICU discharge, approximately 21 days
A patient with IAA-infection is defined as a patient having mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
2
Standard of Care
4
Time to IAPA DiagnosisSecondary· from date of inclusion to date of first sign/symptom of IAA infection, assessed up to ICU discharge, approximately 10 days
Days to influenza-associated pulmonary aspergillosis (IAPA) diagnosis
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
10
8 – 12
Standard of Care
5
3 – 8
Length of ICU StaySecondary· from date of admission in ICU to date of discharge from ICU, approximately 20 days
amount of days at ICU
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
16
8 – 29
Standard of Care
6
3 – 12
Length of Hospital StaySecondary· from date of admission in hospital to date of discharge from hospital, approximately 25 days
Number of days in the hospital
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
25
18 – 45
Standard of Care
12
9 – 35
ICU Mortality - Number of Participant DeathsSecondary· At ICU discharge
survival status
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
7
Standard of Care
9
Hospital Mortality - Number of Participant DeathsSecondary· At hospital discharge
Survival status at hospital discharge
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
8
Standard of Care
10
90-day Mortality - Number of Participant DeathsSecondary· At 90 days after ICU admission
Survival status at 90 days after ICU admission
Group
Value
95% CI
SOC + 'Posaconazole 18 MG/ML'
9
Standard of Care
11
Adverse events — posted to ClinicalTrials.gov
Time frame: 90 days after ICU admission.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) patients with severe influenza.
The investigators will perform an interventional non-blinded randomized controlled multicentric proof-of-concept study in patients with severe influenza admitted to the ICU. Patients will be randomized to the posaconazole prophylaxis group or to the SOC (standard of care) group. Oseltamivir will be started at the discretion of the investigator. Patients in the posaconazole group will receive posaconazole prophylaxis for 7 days.
addendum: pharmacokinetics of posaconazole as prophylaxis for invasive fungal disease on ICU
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
Last refreshed: 8 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03378479.