Prevention of influenza-associated aspergillosis in critically ill patients with Posaconazole

Phase 1

• Conditions: invasive aspergillosis in critically ill patients with influenza pneumonia; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-003270-14-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-29
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified