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Experimental Model to Evaluate Resolution of Pneumonia
Published on: February 17, 2023
The ARDS, Pneumonia, and Sepsis Consortium: Rationale, Design, and Feasibility of a National Platform for Phenotyping
Wesley H Self1, Carolyn S Calfee2, Samuel M Brown3
1Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.
Insights
The ARDS, Pneumonia, and Sepsis (APS) Consortium study is rapidly enrolling critically ill adults. This research is generating valuable data and biospecimens to improve understanding and treatment of these severe conditions.
Area of Science:
- Critical care medicine
- Translational research
- Respiratory and infectious diseases
Background:
- The National Institutes of Health established the ARDS, Pneumonia, and Sepsis (APS) Consortium to advance biological understanding and therapeutic development for these critical illnesses.
- The consortium aims to accelerate the development of new treatments for acute respiratory distress syndrome (ARDS), pneumonia, and sepsis.
Purpose of the Study:
- To determine if the APS Consortium study is efficiently generating data and biospecimens from a large cohort of critically ill adults.
- To facilitate the precise phenotyping of ARDS, pneumonia, and sepsis through comprehensive data and biospecimen collection.
Main Methods:
- A multicenter, longitudinal, prospective observational cohort study involving 4,000 critically ill adults over 4 years.
- Collection of extensive data and biospecimens to characterize participants' health status, acute illness, and recovery.
- Feasibility assessment based on the first 1,000 participants, evaluating recruitment, characteristics, biospecimen collection, and confirmed diagnoses via expert adjudication.
Main Results:
- Recruitment of the first 1,000 participants was completed ahead of schedule in under 13 months.
- Participants had a median age of 64 years, with high rates of vasopressor (75%) and invasive mechanical ventilation (50%) use; 25% experienced in-hospital mortality within 4 weeks.
- High biospecimen collection rates were achieved, including blood (99%), upper respiratory swabs (98%), urine (80%), and gastrointestinal samples (65%). Expert adjudication classified 40% with ARDS, 52% with pneumonia, and 89% with sepsis.
Conclusions:
- The APS Consortium Phenotyping Study is successfully creating a cohort of critically ill patients with severe disease.
- The study is yielding a rich dataset and biospecimen repository crucial for understanding ARDS, pneumonia, and sepsis.
- The study is on track to meet its enrollment goal of 4,000 participants.
Background:
To enhance biological understanding of ARDS, pneumonia, and sepsis and to accelerate therapeutic development in these areas, the National Institutes of Health developed the ARDS, Pneumonia, and Sepsis (APS) Consortium.
Research Question:
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?
Study Design And Methods:
The APS Consortium Phenotyping Study is a multicenter, longitudinal, prospective, observational cohort study aimed at enrolling 4,000 critically ill adults with ARDS, pneumonia, sepsis, or a combination thereof 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 pathophysiologic characteristics. 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.
Results:
The first 1,000 participants were recruited ahead of schedule in < 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 samples, 98% with upper respiratory swabs, 37% with lower respiratory samples, 80% with urine samples, and 65% with gastrointestinal samples. Expert adjudication resulted in 40% classified with ARDS, 52% classified with pneumonia, and 89% classified with sepsis.
Interpretation:
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.
Clinical Trial Registration:
ClinicalTrials.gov; No.: NCT06521502; URL: www.
Clinicaltrials:
gov.
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