Early Diagnosis of Invasive Lung Aspergillosis

NCT05860387 | Recruiting

• 2 other identifiers: EDILANU23-05-00095
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Respiratory Infection; Invasive Pulmonary Aspergillosis

Keywords

biomarkers; qualitative polymerase chain reaction (qPCR); metallomics; mass spectrometry; colonisation; invasive pulmonary aspergillosis; Pentraxin-3

Outcome Measures

Primary Outcomes (1)

• Concentration of IPA on mass spectrometry

  IPA in time will be recognized and analysed in tissue samples (bronchoalveolar lavage fluid, endotracheal aspirate, breath condensate, serum, and urine) of critically ill patients 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. 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 in a prospective study of threshold driven and a continuous response variable from independent control and experimental groups of subjects.

  31 months

Study Arms (2)

Suspicion of IPA at enrolment

Study subjects with suspicion of IPA at enrolment will be included in this study group.

Diagnostic Test: Next generation improvement of early invasive aspergillosis

Probable or proven IPA at enrolment

Study subjects with probable or proven IPA at enrolment will be included in this study group.

Diagnostic Test: Next generation improvement of early invasive aspergillosis

Interventions

Next generation improvement of early invasive aspergillosis DIAGNOSTIC_TEST

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

Probable or proven IPA at enrolment; Suspicion of IPA at enrolment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients (\>18 years) with any respiratory symptoms.

You may qualify if:

• 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)

You may not qualify if:

• \- patients, in whom PTX3, Aspergillus qPCR, and HPLC-FTICR were not performed or were performed after the start of antifungal treatment

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Public Health Institute Ostrava: collaborator
• University Hospital Olomouc: collaborator
• Municipal Hospital Ostrava: collaborator
• Havířov Hospital: collaborator
• Krnov Hospital: collaborator
• University of Ostrava: collaborator

Study Sites (7)

Havířov Hospital

Havířov, Moravian-Silesian Region, 736 01, Czechia

RECRUITING

Krnov Hospital

Krnov, Moravian-Silesian Region, 794 01, Czechia

RECRUITING

Public Health Institute Ostrava

Ostrava, Moravian-Silesian Region, 702 00, Czechia

RECRUITING

University of Ostrava

Ostrava, Moravian-Silesian Region, 703 00, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Municipal Hospital Ostrava

Ostrava, Moravian-Silesian Region, 728 80, Czechia

RECRUITING

University Hospital Olomouc

Olomouc, Olomouc Region, 779 00, Czechia

RECRUITING

Related Publications (38)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

BALF and/or ETA and serum, tissue biopsy (if available), urine (in intubated patients)

MeSH Terms

Conditions

Respiratory Tract Infections; Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases

Study Officials

• Jozef Škarda, Assoc.Prof.,MD,DVM,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 16, 2023
• Study Start: May 31, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7)