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The APS Phenotyping Study

{ "Understanding ARDS, Sepsis, and Pneumonia: The APS Phenotyping Study", "This observational study, called the APS Phenotyping Study, aims to better understand risk factors, how long and severe illnesses are, and recovery for adults with ARDS (Acute Respiratory Distress Syndrome), pneumonia, and/or sepsis (a life-threatening response to infection). Researchers will collect clinical information, questionnaires, and samples like blood, urine, stool, and swabs from the nose, mouth, and rectum. If you are on a breathing machine, samples from a special filter will also be collected. The goal is to classify these conditions and find new ways to treat them. This study is for adults aged 18 and older who are in the intensive care unit (ICU) or another hospital setting and have or are at risk of developing these conditions. The study plans to enroll 4000 participants, but its current status is unclear.", "design": "This is an observational study, meaning researchers will collect information without giving any specific treatments. It aims to enroll 4000 participants.", "commitments": "You would provide clinical data, complete questionnaires, and give samples of blood, urine, stool, and swabs. Some samples will be collected during and after hospitalization, with some follow-up visits at 3 and 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "Some participants will have follow-up visits at 3 and 12 months after hospitalization.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06521502

The APS Phenotyping Study

Recruiting
Not specifiedAges 18+Observational
Vanderbilt University Medical Center
~4,000 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Blood collectionUrine CollectionNasal, oral, and rectal swabsStool collectionHeat Moisture Exchange Filter collectionTracheal Aspirate sample collection

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ARDS, pneumonia, and sepsis classification
Measured over Through day 7

Conditions

ARDS
Sepsis
Pneumonia

Explore related trials

Acute Respiratory Distress SyndromePneumoniaSepticemia

Where it's being run

20 sites across 11 states
California4
Colorado4
Illinois2
Tennessee2
Utah2
Maryland1
Michigan1
Missouri1

Study leadership

  • Wesley H. Self, MD, MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Wesley H. Self, MD, MPH
[email protected]
1-615-936-8047
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

New receipt of invasive mechanical ventilation, non-invasive ventilation, high flow nasal cannula, or supplemental oxygen at a flow rate of ≥ 6 lpm for acute hypoxemia.
Receipt of intravenous infusion of a vasopressor medication for at least one hour. 4. Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) is attributed to an acute inflammatory condition, including but not limited to any of the following:
Any infection including pneumonia.
Aspiration pneumonitis.
Pancreatitis.
Auto-inflammatory condition such as:

Exclusion

Drug overdose (without aspiration, lung injury, pneumonia, or infection).
Trauma (without aspiration, pneumonia, or infection).
Chronic lung disease without suspected infection, aspiration, or inflammation.
Asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, neuromuscular respiratory failure.
Status epilepticus.
Acute pulmonary embolism.
Acute decompensated heart failure.
Diabetic ketoacidosis.
Acute stroke or intracranial hemorrhage.
Acute bleeding (GI bleeding, post-procedural bleeding, hemolysis).
Cytokine release syndrome due to chemotherapy. 12. Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

What this trial measures

  • ARDS, pneumonia, and sepsis classificationThrough day 7

    Classification of critically ill adults into disease categories based on published paradigms, including the Berlin Criteria for ARDS, Sepsis-3 criteria for sepsis, and Centers for Disease Control and Prevention (CDC) criteria for pneumonia.