As an infrastructure at the German Center for Infection Research (DZIF), the Clinical Trial Unit tracks DZIF's study activities in the “Healex Site Management System (SMS)”. Studies are sorted by indication and are continuously updated.

The study register has recently been expanded to include the category “COVID-19”. For the first time, not only DZIF study activities are presented here: In order to provide a comprehensive overview in the current pandemic situation of planned and already active COVID-19 studies in Germany, the Clinical Trial Unit is cooperating with researchers from various German Centers for Health Research and other networks.

For researchers: If your study is not yet included in our portal, please contact the project management of the Clinical Trial Unit (angela.steinbach@uk-koeln.de or vassiliki.dimitriou@uk-koeln.de).

Aspergillosis in COVID19 on ICU

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS

Pulmonary Aspergillosis in Critically Ill COVID19 Patients in Intensive Care Unit - a Multinational Explorative Trial

Status: Active

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

  1. Determine diagnostic performance of BALF-GM for IPA in COVID19
  2. Determine diagnostic performance of BALF-LFD for IPA in COVID19
  3. Determine diagnostic performance of BALF-LFA for IPA in COVID19
  4. Determine diagnostic performance of BALF Aspergillus PCR in COVID19
  5. Determine performance of urine biomarkers for IPA in COVID19
  6. Determine radiological findings on chest imaging in COVID19 patients with and without IPA
  7. Outcome of COVID19 patients on ICU with and without IPA
  8. Length of ICU stay in COVID19 patients with and without IPA
  9. 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

Patient attributes

Inclusion criteria

  1. Patient has PCR confirmed SARS-CoV-2 infection
  2. Bronchoscopy or endotracheal aspiration is performed during routine clinical work (indicated by the treating physician only – no intervention for study purpose only)
  3. 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.

  1. Galactomannan ELISA from BALF or endotracheal aspiration and serum
  2. Aspergillus lateral-flow device from BALF or endotracheal aspiration and serum
  3. Galactomannan lateral-flow assay from BALF or endotracheal aspiration and serum
  4. Aspergillus PCR from BALF or endotracheal aspiration
  5. suPAR, IL-6, and IL-8 from BALF and plasma samples
  6. 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.

Documents (password protected)

Responsibilities in overall trial

Medizinische Universität Graz

  • Tel. 0043/316/385-0

National Coordinating Investigator

Dr. med. Philipp Köhler

National Coordinating Investigator

Priv.-Doz. Dr. med.univ. Dr.scient.med. Jürgen Prattes