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The ARDS, Pneumonia, and Sepsis (APS) Consortium: Rationale, Design, and Feasibility of a National Platform for Phenotyping Critical Illness Syndromes
Journal article   Peer reviewed

The ARDS, Pneumonia, and Sepsis (APS) Consortium: Rationale, Design, and Feasibility of a National Platform for Phenotyping Critical Illness Syndromes

Wesley H Self, Carolyn S Calfee, Samuel M Brown, Marc Moss, Lorraine B Ware, Robert C Hyzy, Nuala J Meyer, John P Reilly, Michael O Harhay, Michael G S Shashaty, …
Chest
07/13/2026
DOI: 10.1016/j.chest.2026.05.053
PMID: 42442528

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Abstract

To enhance biological understanding of acute respiratory distress syndrome (ARDS), pneumonia, and sepsis and accelerate therapeutic development in these areas, the National Institutes of Health developed the ARDS, Pneumonia, and Sepsis (APS) Consortium. Is the APS Consortium study rapidly generating data and biospecimens from a large cohort of critically ill adults with ARDS, pneumonia, and sepsis that will facilitate phenotyping of these syndromes? The APS Consortium Phenotyping Study is a multicenter longitudinal prospective observational cohort study aimed at enrolling 4,000 critically ill adults with ARDS, pneumonia, and/or sepsis over 4 years. Data and biospecimens are collected to characterize many aspects of each participant's chronic health, acute illness, and long-term recovery to facilitate phenotyping-that is, subclassifying ARDS, pneumonia, and sepsis into precise biologically-based subsets with shared pathophysiology. Feasibility of the study was assessed by evaluating the first 1,000 participants in terms of recruitment pace, participant characteristics, biospecimen collection, and proportion with confirmed ARDS, pneumonia, and sepsis based on expert adjudication. The first 1,000 participants were recruited ahead of schedule in less than 13 months. Median age was 64 years, 75% received vasopressors, 50% received invasive mechanical ventilation, and 25% died in the hospital within 4 weeks of enrollment. Biospecimen collection rates were high, with 99% of participants with blood, 98% with upper respiratory swabs, 37% with lower respiratory samples, 80% with urine, and 65% with gastrointestinal samples. Expert adjudication resulted in 40% classified with ARDS, 52% with pneumonia, and 89% with sepsis. The APS Consortium Phenotyping Study is producing a cohort of critically ill adults with ARDS, pneumonia, and sepsis with high severity of disease and a rich set of data and biospecimens. The study will continue to full enrollment of 4,000 participants. Clinicaltrials.gov NCT06521502.
Phenotype Critical Care pneumonia acute respiratory distress syndrome precision medicine recovery sepsis

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