invasive aspergillosis in critically ill patients with influenza pneumonia
Conditions
Interventions
Trade Name: Noxafil
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion 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-ration = 300 with or without (bilateral) infiltrates. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 interval =500 msec 9.Patients with liver cirrhosis (Child C) 10.Participation in another interventional clinical trial 11.Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol 12.Patients or their legal representatives who did not sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza-Associated Aspergillosis in ICU-patients;Secondary Objective: not applicable;Primary end point(s): incidence of influenza associated aspergillosis (IAA infection) at ICU discharge;Timepoint(s) of evaluation of this end point: ICU discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -time to IAA diagnosis -lenght of ICU stay -lenght of hospital stay -30 day mortality -90 day mortality;Timepoint(s) of evaluation of this end point: -IAA diagnosis -ICU discharge -hospital discharge -Day30 -Day 90 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactProf Dr Joost Wauters
UZ Leuven
Outcome results
None listed