Overview

Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients

Status:
Terminated

Trial end date:
2020-06-30

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Universitaire Ziekenhuizen Leuven

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Posaconazole

Criteria

Inclusion Criteria:

1. Written informed consent must be obtained from the patient or his/her legal
representative prior to any study procedures

2. Adult patient (≥ 18 years)

3. 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)

4. Influenza symptoms present for no more than 10 days before ICU admission

5. 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:

1. Patients with age < 18 years

2. Pregnant women (based on a positive serum sample)

3. Expected survival on ICU admission ≤ 48h

4. Patients having influenza symptoms for more than 10 days before ICU admission

5. 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)

6. Patients with known intolerance or hypersensitivity to posaconazole or other azole
antifungal agents

7. Patients that are being treated actively with antifungal agents for invasive
aspergillosis

8. Patients with a QTc (corrected QT interval) interval ≥500 msec

9. Patients with liver cirrhosis (Child C)

10. Participation in another interventional clinical trial -