New Biomarker Testing for Early Detection of Invasive Lung Aspergillosis in Critically Ill Adults

What this Trial Is About

Researchers are investigating invasive pulmonary aspergillosis IPA, a serious lung infection mostly caused by Aspergillus fumigatus, which has increased significantly in critically ill patients, especially those with severe respiratory infections like COVID-19 and H1N1. Current biomarkers only suggest probable IPA, so this study aims to evaluate new low molecular weight substances combined with acute-phase proteins to confirm IPA quickly and accurately. The goal is to improve early diagnosis and treatment outcomes in intensive care patients. This study collects multiple types of samples such as tissue, bronchoalveolar lavage fluid, endotracheal aspirate, breath condensate, serum, and urine from patients suspected of IPA. Using advanced mass spectrometry techniques including MALDI-TOF, researchers will detect specific microbial markers alongside host proteins to confirm infection. Samples will be taken twice weekly until negative results or discharge, and stored samples from before diagnosis may also be analyzed. The study compares groups of patients with suspected IPA and those with probable or proven IPA. Participants will undergo regular testing including imaging, mycological cultures, PCR tests, and biomarker analyses. Data on clinical history, treatment, and biological markers will be collected and analyzed statistically to evaluate the diagnostic accuracy of the new methods. Results will be reported to clinicians in variable timeframes. The primary outcome is the concentration of IPA markers detected by mass spectrometry over 31 months. The study runs until the end of 2026 and involves critically ill adult patients in intensive care units.

Early Diagnosis of Invasive Lung Aspergillosis