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Search / Trial NCT04530799

Prospective Observational Trial of IAPA

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Aug 25, 2020

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Influenza Intensive Care Unit Influenza Associated Pulmonary Aspergillose Invasive Pulmonary Aspergillosis Virus Diseases Respiratory Tract Infections Fungal Lung Diseases

ClinConnect Summary

This clinical trial is studying a condition called influenza-associated pulmonary aspergillosis (IAPA), which can occur in patients with severe influenza who are in the intensive care unit (ICU). The goal of the trial is to understand how often IAPA happens and to identify the risk factors related to both the patients and the germs that cause this condition. Researchers are particularly interested in patients who test positive for the influenza virus and require extended ICU care due to breathing difficulties.

To be eligible for this study, participants must be at least 18 years old and have a positive test for the influenza virus within a specific time frame before or after being admitted to the ICU. They should also need ICU care for more than 24 hours because of serious respiratory problems. It's important to note that patients who are expected to survive less than 48 hours upon ICU admission or are already receiving treatment for certain fungal infections will not be included in the trial. If you or a family member might qualify, participating in this study could help improve understanding of these serious conditions and aid future treatments.

Gender

ALL

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

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Leuven, , Belgium

Paris, , France

Paris, , France

Lille, , France

Groningen, , Netherlands

Roeselare, , Belgium

Paris, , France

Nijmegen, Gelderland, Netherlands

Paris, , France

Brugge, , Belgium

Rennes, , France

Amsterdam, , Netherlands

Amiens, , France

Patients applied

0 patients applied

Trial Officials

Joost Wauters, MD, PhD

Principal Investigator

UZ Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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