IAPAFLU: Prospective Observational Trial of IAPA
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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. This prospective multi-center observational study will assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients in 12 ICUs in The Netherlands, Belgium and France over 4 influenza seasons. The secondary objective of this study is to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza. Patients aged 18 or older admitted to the intensive care unit (ICU) during the inclusion period due severe influenza without classic risk factors defined by the EORTC will be included.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IAPA+ Influenza patients who develop IAPA during ICU admission |
Other: Identification of biomarkers for IAPA via patient sampling
Blood, BAL, microbiome
|
| IAPA- Influenza patients admitted to the ICU not developing IAPA |
Other: Identification of biomarkers for IAPA via patient sampling
Blood, BAL, microbiome
|
Outcome Measures
Primary Outcome Measures
- The incidence of IAPA-infection at ICU discharge [from date of admission in ICU assessed up to ICU discharge, approximately 21 days]
The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.
Secondary Outcome Measures
- Time to IAPA diagnosis [from date of admission in ICU assessed up to ICU discharge, approximately 21 days]
The diagnosis of IAPA will be made by the treating physician, according to a strict case definition.
- Length of ICU stay [from date of admission in ICU assessed up to ICU discharge, approximately 21 days]
- Length of hospital stay [from date of admission in hospital assessed up to hospital discharge, approximately 30 days]
- ICU mortality [up to ICU discharge, approximately 21 days]
- Hospital mortality [from date of admission in hospital assessed up to hospital discharge, approximately 30 days]
- 30-day mortality [30 days]
- 90-day mortality [90 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6525GA |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Principal Investigator: Joost Wauters, MD, PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IAPAFLU