Phase 4
N=88
Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients
Aspergillosis; Pulmonary, Invasive (Etiology)
Bottom Line
View on ClinicalTrials.gov: NCT03378479 ↗Enrolled (actual)
88
Serious AEs
27.4%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With IAA-infection at ICU Discharge — 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SOC +Posaconazole 18 MG/ML (milligram/milliliter) (Drug); standard of care (SOC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With IAA-infection at ICU Discharge |
2; 4 | — |
| SECONDARY Time to IAPA Diagnosis |
10; 5 | — |
| SECONDARY Length of ICU Stay |
16; 6 | — |
| SECONDARY Length of Hospital Stay |
25; 12 | — |
| SECONDARY ICU Mortality - Number of Participant Deaths |
7; 9 | — |
| SECONDARY Hospital Mortality - Number of Participant Deaths |
8; 10 | — |
| SECONDARY 90-day Mortality - Number of Participant Deaths |
9; 11 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained from the patient or his/her legal representative prior to any study procedures
- Adult patient (≥ 18 years)
- PCR-confirmed influenza based on nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) within 7 days before ICU admission or within 48 hours after ICU admission. If PCR is not available a positive result of a rapid test is required (a negative rapid test does not imply absence of influenza and thus requires confirmation by PCR)
- Influenza symptoms present for no more than 10 days before ICU admission
- Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with an respiratory rate ≥ 25x/min and a paO2/fiO2-ratio (fraction of inspired oxygen) ≤ 300 with or without (bilateral) infiltrates.
Exclusion Criteria
- Patients with age < 18 years
- Pregnant women (based on a positive serum sample)
- Expected survival on ICU admission ≤ 48h
- Patients having influenza symptoms for more than 10 days before ICU admission
- Patients being transferred from another hospital ward or another hospital who already have mycological evidence for an IAA-infection (based on sputum, BA or BAL culture, BAL or serum GM)
- Patients with known intolerance or hypersensitivity to posaconazole or other azole antifungal agents
- Patients that are being treated actively with antifungal agents for invasive aspergillosis
- Patients with a QTc (corrected QT interval) interval ≥500 msec
- Patients with liver cirrhosis (Child C)
- Participation in another interventional clinical trial -
Data sourced from ClinicalTrials.gov (NCT03378479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.