NCT05860387 Early Diagnosis of Invasive Lung Aspergillosis
| NCT ID | NCT05860387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Ostrava |
| Condition | Respiratory Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-05-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 low molecular weight substances (secondary metabolites) combined with acute-phase proteins (pentraxin 3) allows very reliable immediate confirmation of IPA. In tissue samples, bronchoalveolar lavage fluid, endotracheal aspirate, breath condensate, serum, and urine of critically ill patients, the investigators will be able to recognize and confirm IPA in time using highly sensitive mass spectrometry detecting specific microbial siderophores in correlation with a significantly increased concentration of acute-phase host protein (pentraxin 3) within hours of the beginning of the invasion of lung tissue. Through a prospective multicentre study, the investigators will evaluate the benefit of new biomarkers in non-invasive IPA confirmation, improve the IPA diagnostic algorithm and transfer the detection method to MALDI-TOF spectrometers widely used in Clinical laboratories in the Czech Republic. In MALDI-TOF mass spectrometry, the ion source is matrix-assisted laser desorption/ionization (MALDI), and the mass analyser is a time-of-flight (TOF) analyser. The study results will contribute to a high clarity of IPA cases, the accurate introduction of antifungal therapy, and a better prognosis of survival of critically ill patients.
Eligibility Criteria
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
Contact & Investigator
Jozef Škarda, Assoc.Prof.,MD,DVM,PhD
PRINCIPAL INVESTIGATOR
University Hospital Ostrava
Frequently Asked Questions
Who can join the NCT05860387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05860387 currently recruiting?
Yes, NCT05860387 is actively recruiting participants. Contact the research team at jiri.hyncica@fno.cz for enrollment information.
Where is the NCT05860387 trial being conducted?
This trial is being conducted at Havířov, Czechia, Krnov, Czechia, Ostrava, Czechia, Ostrava, Czechia and 3 additional locations.
Who is sponsoring the NCT05860387 clinical trial?
NCT05860387 is sponsored by University Hospital Ostrava. The principal investigator is Jozef Škarda, Assoc.Prof.,MD,DVM,PhD at University Hospital Ostrava. The trial plans to enroll 150 participants.