RecruitingNCT05860387

Early Diagnosis of Invasive Lung Aspergillosis

Sponsor

University Hospital Ostrava

Enrollment

150 participants

Start Date

May 31, 2023

Study Type

OBSERVATIONAL

Conditions

Invasive Pulmonary Aspergillosis Respiratory Infection

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study focuses on the early detection of invasive pulmonary aspergillosis (IPA) — a life-threatening fungal infection of the lungs caused by Aspergillus mold, which primarily strikes severely ill patients in intensive care units. IPA is often diagnosed too late, leading to high mortality rates. Researchers are testing new diagnostic tools including a blood protein called PTX3, Aspergillus DNA detection by PCR, and advanced mass spectrometry methods to see whether these can identify the infection earlier than current standard tests. The study enrolls critically ill patients already on mechanical ventilation or with severe respiratory distress who undergo bronchoscopy or endotracheal suctioning as part of their care. Patients in whom the specialized tests could not be completed or were done after antifungal treatment had already started are excluded from analysis. Participant data and respiratory samples are analyzed in comparison with conventional culture and imaging methods. Early detection of Aspergillus infections is urgently needed because antifungal therapy is only effective when started promptly, and current diagnostic delays are a major reason why mortality from IPA remains so high — often exceeding 50% in immunocompromised patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNext generation improvement of early invasive aspergillosis

Next generation improvement of early invasive aspergillosis test is intended to determine the suitability of new potential biomarkers of aspergillosis.