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

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 - Posaconazole prophylaxis for prevention of IAA POSA-FLU

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46362

Enrollment

Registered

2018-07-05

Start date

2018-02-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza-associated aspergillosis

Interventions

The intervention group receives 300 mg posaconazole once daily intravenously (after a loading dose of 300 mg twice daily) during 7 days, in addition to standard of care (SOC). The control group rece

Eligibility

Age

18 Years to 99 Years

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 in nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) fluid within 7 days prior to 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 means of PCR); 4. Influenza symptoms present for no more than 10 days prior to ICU admission; 5. Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with a respiratory rate >= 25/min. and a PaO2/FiO2 ratio

Exclusion criteria

Exclusion criteria: 1. Pregnant women (based on a positive serum sample); 2. Expected survival on ICU admission = 500 milliseconds on electrocardiography (ECG); 8. Patients with liver cirrhosis (Child-Pugh classification C); 9. Participation in another investigational clinical trial; 10. Any disorder which, in the investigator's opinion, might jeopardize subject's safety or compliance with the protocol

Design outcomes

Primary

Measure	Time frame
The difference in IAA incidence at ICU discharge between the intervention and control group.	—

Secondary

Measure	Time frame
- Time to IAA diagnosis - Length of ICU stay - Length of hospital stay - Overall mortality - 30-day mortality - 90-day mortality - Presence of markers of MAS in blood - Cytokine production by peripheral blood mononuclear cells (Nijmegen site only) - Reactive oxygen species (ROS) production by peripheral blood polymorphonuclear cells/neutrophils (Nijmegen site only) - Frequencies in single nucleotide polymorphisms/mutations in relevant genes (Nijmegen site only)	—

Measure

Time frame

- Time to IAA diagnosis - Length of ICU stay - Length of hospital stay - Overall mortality - 30-day mortality - 90-day mortality - Presence of markers of MAS in blood - Cytokine production by peripheral blood mononuclear cells (Nijmegen site only) - Reactive oxygen species (ROS) production by peripheral blood polymorphonuclear cells/neutrophils (Nijmegen site only) - Frequencies in single nucleotide polymorphisms/mutations in relevant genes (Nijmegen site only)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)