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4,000 ICU patients join quest to unravel deadly lung and blood infections

NCT ID NCT06521502

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is enrolling 4,000 adults in intensive care with ARDS, sepsis, or pneumonia. Researchers will collect blood, urine, and swab samples, plus track recovery for up to a year. The goal is to identify different patient subtypes and find clues that could lead to better treatments in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify biomarkers and risk factors that improve diagnosis and treatment for ARDS, sepsis, and pneumonia.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any new drug or therapy, so benefits for patients are indirect and long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study enrolls hospitalized adult patients ≥18 years who have or are at high risk of developing ARDS, pneumonia, and/or sepsis.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be eligible for enrollment, a patient must meet all the following inclusion criteria at the time of the first study-specified biospecimen collection (Time 0): 1. Age ≥ 18 years old 2. Admitted (or planned to be admitted) to an intensive care unit (ICU) or other in-patient hospital location where IV vasopressors or advanced respiratory support (invasive mechanical ventilation, non-invasive ventilation, or high flow nasal cannula) are routinely provided (referred to as an "eligible unit.") 3. Acute cardiovascular or pulmonary organ dysfunction defined by meeting at least one of the two criteria below: * 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. a. Patients who use chronic oxygen therapy are eligible to participate if they are receiving at least 6 lpm higher than their baseline oxygen requirement (e.g., a patient on 3 lpm O2 at baseline is eligible if they require ≥9 lpm for hypoxemia) or are started on advanced respiratory support (invasive mechanical ventilation, non- invasive ventilation, or high flow nasal cannula). * 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: 1. Hemophagocytic lymphohistiocytosis. 2. Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations. 3. Suspected cryptogenic organizing pneumonia presenting acutely. 4. Suspected diffuse alveolar hemorrhage. 5. Suspected acute anaphylaxis. 6. Suspected acute pulmonary drug toxicity. Exclusion Criteria: To be eligible for enrollment, a patient must not meet any of the following exclusion criteria at the time of the first study-specified biospecimen collection (Time 0): 1. Patient/legally authorized representative (LAR) declines participation. 2. Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for \> 48 hours. 3. Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days). 4. Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment. 5. Patient desires comfort measures only. 6. Patient is a prisoner. 7. Patient had out-of-hospital cardiac arrest leading to this hospitalization. 8. Residence immediately before this hospitalization in a long-term acute care facility. 9. Presence of tracheostomy for respiratory failure. 10. Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate). 11. Suspected cause of the patient's acute cardiovascular and/or pulmonary dysfunction (inclusion criterion #3) is an alternative condition (not ARDS, pneumonia, or sepsis), including but not limited to the list below: * 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.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Critical Illness infectious disease with sepsis pneumonia Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARDS Pneumonia Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Denver Health and Hospital Authority

    RECRUITING

    Denver, Colorado, 80204, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fresno Community Hospital and Medical Center

    RECRUITING

    Fresno, California, 93721, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Johns Hopkins Univeristy

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Meharry Medical College

    RECRUITING

    Nashville, Tennessee, 37208, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • San Francisco General Hospital

    RECRUITING

    San Francisco, California, 94110, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

  • UC Health Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Colorado, Denver

    RECRUITING

    Denver, Colorado, 80045, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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