A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe…
ID
Source
Brief title
Condition
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of IAPA-infection at ICU discharge
Secondary outcome
Time to IAPA diagnosis, length of stay at ICU/hospital and mortality
Background summary
Invasive pulmonary aspergillosis was shown to be a complication of severe
influenza infections in immunocompromised patients as well as in
immunocompetent patients and is associated with a high mortality. Antifungal
prophylaxis might prevent influenza-associated pulmonary aspergillosis (IAPA)
and thus might improve the outcome in patients with severe influenza. However,
clinical related risk factors should be identified to assess whether a patient
will benefit from antifungal prophylaxis.
Study objective
A prospective multi-center observational study to assess the incidence of
influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to
identify host- and pathogen related risk factors for IAPA in EORTC negative ICU
patients with severe influenza.
Study design
Prospective multi-center observational study.
Study burden and risks
The nature and extent of the burden and risks associated with participation are
considered negligible, as the proposed study does not apply an intervention to
the patients. The only burden will be collection of samples which are
procedures of minimal additional risk.
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Patients with a PCR-positive respiratory virus panel (RVP) result for influenza
within 96 hours before or 48 hours after ICU admission.
Patients who require ICU admission for more than 24 hours for severe influenza.
Patients who have respiratory distress (respiratory rate >= 25x/minute and
paO2/fiO2 < 300 with or without bilateral infiltrates) as the main reason for
ICU admission.
Patients who do not have an EORTC host factor.
Patients who are at least 18 years of age.
Exclusion criteria
Patients with age < 18 years as extensive sampling is required
Expected survival on ICU admission <= 48h
Patients that are being treated actively with antifungal agents for invasive
aspergillosis.
Patients or their legal representatives who did not sign the informed consent
form.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04530799 |
| CCMO | NL74862.091.20 |