Early diagnosis of invasive lung aspergillosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Jozef Škarda, Assoc.Prof.,MD,DVM,PhD — University Hospital Ostrava
• Study coordinator: Jiří Hynčica
• Email: jiri.hyncica@fno.cz
• Phone: 0042059737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.