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Early Diagnosis of Invasive Lung Aspergillosis

Recruitingn/aAges 18 Years - anyAllUniversity Hospital Ostrava
NCT05860387 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The last decade has seen a significant increase in secondary Aspergillus infections, not only due to primary hypersensitivity, and immunodeficiency based on oncological diseases and their therapy, but mainly due to a rise in severe respiratory infections (H1N1, COVID-19, bacterial infections). This is most evident in critically ill patients whose life is threatened by invasive pulmonary aspergillosis (IPA), with over 90 % of cases being caused by Aspergillus fumigatus. In recent decades, various biomarkers with well-known limits of use (Aspergillus DNA, galactomannan, 1,3-ß-D-glucan) have been used for early diagnosis of IPA. However, the clinical need to clearly distinguish the onset of IPA from colonization is much more significant. The current biomarkers only provide "probable IPA" interpretation, and the diagnosis is rarely confirmed. Based on our preliminary studies, the use of new

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📋 Eligibility rules (as published)
Inclusion Criteria: * respiratory rate ≥ 30 breaths/min * PaO2/FiO2 ratio ≤ 250 * multilobar infiltrates * confusion/disorientation * uremia (blood urea nitrogen level ≥ 20mg/dL) * leucocytosis (white blood cell count \> 12000/mL) or * leukopenia (white blood cell count \< 4 x 109/L) * thrombocytopenia (platelet count \< 100 x 109/L) * hyperthermia (core temperature \> 38 °C) * hypothermia (core temperature \< 36 °C) * hypotension requiring aggressive fluid resuscitation * invasive mechanical ventilation and septic shock requiring vasopressors * Bronchoalveolar Lavage Fluid (BALF) and/or Endotracheal Aspirate (ETA) Exclusion Criteria: \- patients, in whom PTX3, Aspergillus qPCR, and HPLC-FTICR were not performed or were performed after the start of antifungal treatment
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What it tests

  • Next generation improvement of early invasive aspergillosis
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Where

7 sites
Havířov Hospital
Havířov, Czechia
Krnov Hospital
Krnov, Czechia
Public Health Institute Ostrava
Ostrava, Czechia
University of Ostrava
Ostrava, Czechia
University Hospital Ostrava
Ostrava, Czechia
Municipal Hospital Ostrava
Ostrava, Czechia
University Hospital Olomouc
Olomouc, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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