Aspergillus fumigatus and Aspergillosis in 2019.
Jean-Paul Latgé, Georgios Chamilos
https://pubmed.ncbi.nlm.nih.gov/31722890Actively Recruiting
Age: 18Years +
All Genders
ID05860387
Early Diagnosis of Invasive Lung Aspergillosis
Led by University Hospital Ostrava · Updated on 2023-09-07
150
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital Ostrava
Lead Sponsor
P
Public Health Institute Ostrava
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Early Diagnosis of Invasive Lung Aspergillosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Respiratory rate of 30 breaths per minute or more
- PaO2/FiO2 ratio of 250 or less
- Multilobar infiltrates on imaging
- Confusion or disorientation
- Uremia with blood urea nitrogen level 20 mg/dL or higher
- White blood cell count above 12,000/mL or below 4 x 10^9/L
- Platelet count below 100 x 10^9/L
- Core body temperature above 38 °C or below 36 °C
- Hypotension needing aggressive fluid resuscitation
- Receiving invasive mechanical ventilation and septic shock requiring vasopressors
- Availability of Bronchoalveolar Lavage Fluid (BALF) and/or Endotracheal Aspirate (ETA) samples
You will not qualify if you...
- Patients who did not have PTX3, Aspergillus qPCR, and HPLC-FTICR tests performed before starting antifungal treatment or had these tests only after treatment began
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - From diagnosis until at least 2 consecutive negative results are obtained or discharge from intensive care
Participants with suspected invasive pulmonary aspergillosis (IPA) undergo collection of samples twice a week for analysis, including tests such as galactomannan screening, PTX3, Aspergillus qPCR, and mass spectrometry. Stored samples taken prior to diagnosis may also be analyzed to aid early detection.
Twice weekly sample collections
Long-term Monitoring
Duration - 6 months
Participants are classified at 6 months after diagnosis as having possible, probable, or proven IPA. Clinical and biological data, including imaging and treatment outcomes, are collected to monitor disease progression and response.
Follow-up assessments as determined by clinical care
Trial Site Locations
Total: 7 locations
1
Havířov Hospital
Havířov, Moravian-Silesian Region, Czechia, 736 01
Actively Recruiting
2
Krnov Hospital
Krnov, Moravian-Silesian Region, Czechia, 794 01
Actively Recruiting
3
Public Health Institute Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 702 00
Actively Recruiting
4
University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 703 00
Actively Recruiting
5
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Actively Recruiting
6
Municipal Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 728 80
Actively Recruiting
7
University Hospital Olomouc
Olomouc, Olomouc Region, Czechia, 779 00
Actively Recruiting
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Research Team
J
Jiří Hynčica
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Diagnostic value of serum galactomannan, (1,3)-β-d-glucan, and Aspergillus fumigatus-specific IgA and IgG assays for invasive pulmonary aspergillosis in non-neutropenic patients.
R Dobias, P Jaworska, H Tomaskova...
https://pubmed.ncbi.nlm.nih.gov/29575150Defining and managing COVID-19-associated pulmonary aspergillosis: the 2020 ECMM/ISHAM consensus criteria for research and clinical guidance.
Philipp Koehler, Matteo Bassetti, Arunaloke Chakrabarti...
https://pubmed.ncbi.nlm.nih.gov/33333012Hybrid Imaging of Aspergillus fumigatus Pulmonary Infection with Fluorescent, 68Ga-Labelled Siderophores.
Joachim Pfister, Dominik Summer, Milos Petrik...
https://pubmed.ncbi.nlm.nih.gov/31979017Prevalence of putative invasive pulmonary aspergillosis in critically ill patients with COVID-19.
Alexandre Alanio, Sarah Dellière, Sofiane Fodil...
https://pubmed.ncbi.nlm.nih.gov/32445626Antibody-guided in vivo imaging of Aspergillus fumigatus lung infections during antifungal azole treatment.
Sophie Henneberg, Anja Hasenberg, Andreas Maurer...
https://pubmed.ncbi.nlm.nih.gov/33731708Galactomannan in bronchoalveolar lavage fluid: a tool for diagnosing aspergillosis in intensive care unit patients.
Wouter Meersseman, Katrien Lagrou, Johan Maertens...
https://pubmed.ncbi.nlm.nih.gov/17885264Diagnostic Accuracy of Bronchoalveolar Lavage Fluid Galactomannan for Invasive Aspergillosis.
Xun-Jie Cao, Ya-Ping Li, Li-Min Xie...
https://pubmed.ncbi.nlm.nih.gov/33335924Synthesis, nature and utility of universal iron chelator - Siderophore: A review.
Azmi Khan, Pratika Singh, Amrita Srivastava
https://pubmed.ncbi.nlm.nih.gov/29103733Distinct roles for intra- and extracellular siderophores during Aspergillus fumigatus infection.
Markus Schrettl, Elaine Bignell, Claudia Kragl...
https://pubmed.ncbi.nlm.nih.gov/17845073