Status | Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|---|
Active |
Pulmonary Aspergillosis in Critically Ill COVID19 Patients in Intensive Care Unit - a Multinational Explorative Trial
Purpose / Objectives
Primary Outcome
The primary objective of this study is to determine the prevalence of IPA in patients with critical COVID19 in intensive care units.
Secondary Outcomes
- Determine diagnostic performance of BALF-GM for IPA in COVID19
- Determine diagnostic performance of BALF-LFD for IPA in COVID19
- Determine diagnostic performance of BALF-LFA for IPA in COVID19
- Determine diagnostic performance of BALF Aspergillus PCR in COVID19
- Determine performance of urine biomarkers for IPA in COVID19
- Determine radiological findings on chest imaging in COVID19 patients with and without IPA
- Outcome of COVID19 patients on ICU with and without IPA
- Length of ICU stay in COVID19 patients with and without IPA
- Prognostic potential of plasma and BALF soluble urokinase activator receptor (suPAR), IL-6, and IL-8 in COVID19 patients with and without IPA (single measurements and kinetics)
Diagnosis
- COVID-19 infection
- Invasive aspergillosis
Target population
Inclusion criteria
- Patient has PCR confirmed SARS-CoV-2 infection
- Bronchoscopy or endotracheal aspiration is performed during routine clinical work (indicated by the treating physician only – no intervention for study purpose only)
- Chest imaging (e.g. CT chest scan or chest x-ray) available +/- 7 days of bronchoscopy/endotracheal aspiration
Exclusion criteria
<18 years of age
Intervention
After the recruiting phase of the study the following parameters will be tested from the obtained specimens and samples.
- Galactomannan ELISA from BALF or endotracheal aspiration and serum
- Aspergillus lateral-flow device from BALF or endotracheal aspiration and serum
- Galactomannan lateral-flow assay from BALF or endotracheal aspiration and serum
- Aspergillus PCR from BALF or endotracheal aspiration
- suPAR, IL-6, and IL-8 from BALF and plasma samples
- GM, triacetylfusarinine C from urine samples
All laboratory tests performed for study purposes will be done anonymized. Only left-over samples obtained during routine clinical work will be collected for this study. No intervention to the patients will be performed for study purposes only.
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Responsibilities in overall study
Sponsor
Medizinische Universität Graz
- Tel. 0043/316/385-0
(National) Coordinating Investigator
Priv.-Doz. Dr. med.univ. Dr.scient.med. Jürgen Prattes