Early diagnosis of invasive lung aspergillosis

This study is trying to see if new tests can help doctors diagnose lung infections caused by fungus earlier in critically ill patients.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Ostrava (other)
• Locations: 7 sites (Havířov, Moravian-Silesian Region and 6 other locations)
• Trial ID: NCT05860387 on ClinicalTrials.gov

What this trial studies

This observational study aims to improve the early diagnosis of invasive pulmonary aspergillosis (IPA) in critically ill patients by utilizing new biomarkers and advanced analytical techniques. It will involve collecting various samples from patients suspected of having IPA, with analyses conducted twice a week until negative results are obtained or the patient is discharged. The study will compare results from control and experimental groups to assess the effectiveness of these new diagnostic methods over a three-year period across multiple intensive care units.

Who should consider this trial

Good fit: Ideal candidates for this study are critically ill patients exhibiting symptoms such as respiratory distress, confusion, and signs of infection requiring intensive care.

Not a fit: Patients who have already started antifungal treatment or for whom the necessary diagnostic tests were not performed will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of invasive lung aspergillosis, potentially improving patient outcomes and survival rates.

How similar studies have performed: While there have been studies utilizing various biomarkers for IPA diagnosis, this approach combining new low molecular weight substances and advanced techniques is relatively novel.

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

Where this trial is running

Havířov, Moravian-Silesian Region and 6 other locations

• Havířov Hospital — Havířov, Moravian-Silesian Region, Czechia (RECRUITING)
• Krnov Hospital — Krnov, Moravian-Silesian Region, Czechia (RECRUITING)
• Public Health Institute Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
• University of Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
• University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
• Municipal Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
• University Hospital Olomouc — Olomouc, Olomouc Region, Czechia (RECRUITING)

Study contacts

• Principal investigator: Jozef Škarda, Assoc.Prof.,MD,DVM,PhD — University Hospital Ostrava
• Study coordinator: Jiří Hynčica

Conditions: Respiratory Infection, Invasive Pulmonary Aspergillosis, biomarkers, qualitative polymerase chain reaction, metallomics, mass spectrometry, colonisation, invasive pulmonary aspergillosis