Brief Summary

Acute respiratory distress syndrome (ARDS) is a major contributor to ICU mortality and is characterised by hypoxaemia and pulmonary oedema. Pathomechanisms include barrier breakdown, immunopathology, haemostatic derailment and dysbiosis; however, the actual sequence of events and how they cumulatively lead to lung failure remains unclear. Although ARDS is frequently triggered by pneumonia, it can also occur as a result of trauma, aspiration or non-pulmonary causes. Importantly, ARDS is highly heterogeneous; growing evidence points to aetiology-specific pathomechanisms - a circumstance that explains why attempts to develop specific drugs or timely diagnostic markers have so far failed. A comprehensive analysis of key microenvironmental and haemostasis-related parameters of the lung, combined with multidimensional quantitative image features derived from chest CT scans (radiomics), will enable us to i) identify ARDS phenotypes with different biological characteristics and ii) generate new hypotheses regarding aetiology- or subgroup-specific mechanisms, molecular markers and therapeutic options. Our approach is based on ICU management of our patients guided by bronchoalveolar lavage fluid (BALF). Together with previously sampled cases and new samples collected as part of this study, our cohort will consist of patients with i) COVID-19-associated ARDS, ii) ARDS associated with other viral pneumonia, iii) ARDS associated with bacterial pneumonia, and iv) ARDS of non-pulmonary origin. Bacterial and fungal co-infections and superinfections are recorded in all patients and taken into account in the stratification. Patients with pneumonia without ARDS, as well as ventilated patients without underlying lung disease, serve as controls. To characterise the microbial lung microenvironment, the investigators combine data from routine microbiological diagnostics with microbiome sequencing and metabolomics. In addition, the investigators conduct comprehensive and longitudinal immune and haemostatic profiling by regularly analysing immune cells, cytokines and parameters of immune thrombosis in BALF and blood. Multi-omics integration then identifies phenotypic subgroups by merging all multimodal datasets - including radiomics. Selected samples from identified clusters are then further characterised using single-cell sequencing to uncover specific features/markers and pathomechanisms of the respective ARDS subtypes. Although it is clear that the pathogenesis of ARDS is multifactorial, comprehensive studies that integrate all relevant parameters are rare. Radiomics is increasingly recognised as a powerful tool for capturing the clinical status of ARDS in detail; however, to date, this imaging data has not been systematically linked to other omics readouts. The investigators aim to bridging this gap by conducting a thorough investigation across various ARDS aetiologies in the present study, incorporating all identifiable key factors. Our interdisciplinary team comprises basic immunologists, infectious disease and computational biologists, as well as clinicians with expertise in ARDS, infectious diseases, immunothrombosis and radiology.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

130

participants targeted

Target at P50-P75 for all trials

Timeline

49mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Progress1%

Jun 2026Jun 2030

First Submitted

Initial submission to the registry

May 11, 2026

Completed

21 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed

7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

May 11, 2026

Last Update Submit

June 2, 2026

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDSBALFCOVID-19InfluenzaCo-InfectionPneumoniaviralbacterial

Outcome Measures

Primary Outcomes (1)

ARDS phenotypes
The application of multi-omics cluster analysis to reveal any distinct ARDS phenotypes or subgroup-specific characteristics.
4 years