Observational study on influenza-associated pulmonary aspergillosis in ICU patients

Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors

This study is looking at how common a lung infection linked to the flu is in ICU patients and what factors might increase the risk, while also trying to find markers that could help identify who might need preventive treatment.

Quick facts

• Study type: Observational
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Locations: 12 sites (Brugge and 11 other locations)
• Trial ID: NCT04530799 on ClinicalTrials.gov

What this trial studies

This prospective multi-center observational study aims to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and identify risk factors related to both the host and the pathogen. Conducted across 12 ICUs in The Netherlands, Belgium, and France over four influenza seasons, the study will include patients aged 18 and older who are admitted to the ICU due to severe influenza without classic EORTC risk factors. The study will also focus on identifying biomarkers for IAPA through patient sampling to better understand which patients may benefit from antifungal prophylaxis.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 18 or older with severe influenza requiring admission and without classic EORTC risk factors.

Not a fit: Patients under 18 years old or those with expected survival of less than 48 hours upon ICU admission may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for ICU patients with severe influenza by identifying those who would benefit from antifungal prophylaxis.

How similar studies have performed: While the approach of assessing IAPA in ICU patients is novel, previous studies have indicated a high mortality associated with this condition, suggesting a need for further investigation.

Eligibility 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

Where this trial is running

Brugge and 11 other locations

• AZ St-Jan — Brugge, Belgium (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)
• AZ Delta — Roeselare, Belgium (Recruiting)
• Amiens-Picardie University Hospital — Amiens, France (Recruiting)
• Centre Hospitalier REgional Universitaire de Lille — Lille, France (Recruiting)
• Henri Mondor Hopital — Paris, France (Recruiting)
• Hopital Bichat — Paris, France (Recruiting)
• Hopital Lariboisiere — Paris, France (Recruiting)
• Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes — Rennes, France (Recruiting)
• Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
• AmsterdamUMC, locatie VUmc — Amsterdam, Netherlands (Recruiting)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)

Study contacts

• Principal investigator: Joost Wauters, MD, PhD — UZ Leuven
• Study coordinator: Joost Wauters, MD, PhD

Conditions Influenza With Pneumonia; Pulmonary Aspergillosis; Influenza; Intensive Care Unit; Influenza-associated pulmonary aspergillose; Invasive Pulmonary Aspergillosis; Virus Diseases; Respiratory tract infections