Status:
COMPLETED
Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Aspergillosis; Pulmonary, Invasive (Etiology)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Detailed Description
Critically ill patients with PCR-confirmed influenza criteria) are eligible for inclusion in this study and will be randomized to or the posaconazole prophylaxis group or the SOC group. If a patient ...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
December 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03378479
Start Date
December 27 2017
End Date
March 30 2021
Last Update
April 8 2025
Active Locations (12)
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1
AZ Sint Jan
Bruges, Belgium, 8000
2
UZ Gent
Ghent, Belgium, 9000
3
UZ Leuven
Leuven, Belgium, 3000
4
AZ Delta
Roeselare, Belgium, 8800