EUCTR2017-003270-14-NLActive, not recruitingPhase 1
A phase IV, interventional, non-blinded, randomized, controlled, multicenter study of Posaconazole prophylaxis for the prevention of influenza-associated aspergillosis (IAA) in critically ill patients
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 88
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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) fluid within 7 days before ICU admission or within 48 hours after ICU admission. If PCR is not available, a positive result of a rapid antigen test is required (a negative rapid antigen 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 a respiratory rate = 25x/min. and a PaO2/FiO2-ratio = 300 with or without (bilateral) infiltrates on radiographic chest studies
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
Exclusion Criteria
- •1. Pregnant women (based on a positive serum sample )
- •2. Expected survival on ICU admission = 48h
- •3. Patients being transferred from another hospital ward or another hospital who already have mycological evidence of IA (based on sputum, BA or BAL fluid culture, BAL fluid or serum GM; also see 2.3 Primary Endpoints for a definition of IA)
- •4. Patients with known intolerance of or hypersensitivity to posaconazole
- •5. Patients actively treated with antifungal agents with activity against Aspergillus species
- •6. Patients actively treated with rifampicin or rifabutin
- •7. Patients with a QTc interval = 500 milliseconds on electrocardiography (ECG)
- •8. Patients with liver cirrhosis (Child-Pugh classification C)
- •9. Participation in another interventional clinical trial
- •10. Any disorder which, in the investigator’s opinion, might jeopardize subject’s safety or compliance with the protocol when participating in this study
Investigators
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