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ARDSNCT06521502

The APS Phenotyping Study

An observational study of ARDS and Sepsis, run by Vanderbilt University Medical Center at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ARDS, Sepsis, Pneumonia
What is being tested?
Blood collection, Urine Collection and Nasal, oral, and rectal swabs
How many people
4,000 participants
Where
20 sitesUnited States
Study dates
25 Jul 2024to 30 Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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):
  • Age ≥ 18 years old
  • 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.")
  • 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.
  • 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).
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  • Receipt of intravenous infusion of a vasopressor medication for at least one hour.
  • 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:
  • Hemophagocytic lymphohistiocytosis.
  • Suspected acute rheumatologic or auto-immune disease with pulmonary or cardiovascular manifestations.
  • Suspected cryptogenic organizing pneumonia presenting acutely.
  • Suspected diffuse alveolar hemorrhage.
  • Suspected acute anaphylaxis.
  • Suspected acute pulmonary drug toxicity.

Who cannot join

  • 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):
  • Patient/legally authorized representative (LAR) declines participation.
  • Acute cardiovascular or pulmonary organ dysfunction (inclusion criterion #3) has been present for > 48 hours.
  • Patient has been in an eligible unit (inclusion criterion #2) for more than 120 hours (five days).
  • Patient is no longer expected to meet the acute cardiovascular or pulmonary organ dysfunction inclusion criterion (inclusion criterion #3) 24 hours after enrollment.
  • Patient desires comfort measures only.
Show all 24Show fewer
  • Patient is a prisoner.
  • Patient had out-of-hospital cardiac arrest leading to this hospitalization.
  • Residence immediately before this hospitalization in a long-term acute care facility.
  • Presence of tracheostomy for respiratory failure.
  • Home invasive mechanical ventilation or non-invasive ventilation (except patients with non-invasive ventilation prescribed as a treatment for a sleep disorder may participate).
  • 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.
  • Inability or unwillingness to complete study-specified blood draws, for example, due to local policies about hemoglobin thresholds for research blood draws.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wesley H. Self, MD, MPH contact

1-615-936-8047

wesley.self@vumc.org

Jillian P. Rhoads, PhD contact

1-615-936-3773

jillian.p.rhoads.1@vumc.org

20 sites in 1 country

United States20 sites, 20 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Robert Hyzy, MD, rhyzy@med.umich.edu

    Recruiting

  • Johns Hopkins Univeristy

    Baltimore, Maryland, 21218

    Dale Needham, MD, PhD, dneedha2@jh.edu

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Richard Wunderink, MD, r-wunderink@northwestern.edu

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Krysta Wolfe, MD, krysta.wolfe@uchicagomedicine.org

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    R. Duncan Hite, MD, hitern@ucmail.uc.edu

    Recruiting

  • University of Colorado, Denver

    Denver, Colorado, 80045

    Marc Moss, MD, marc.moss@cuanschutz.edu

    Recruiting

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

    Jason Mansoori, MD, jason.mansoori@dhha.org

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    William Janssen, MD, janssenw@njhealth.org

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Christina Barkauskas, MD, christina.barkauskas@duke.edu

    Recruiting

  • Fresno Community Hospital and Medical Center

    Fresno, California, 93721

    Eyad Almasri, MD, eyad.almasri@ucsf.edu

    Recruiting

  • UC Health Medical Center of the Rockies

    Loveland, Colorado, 80538

    Eric Stevens, MD, Eric.Stevens@uchealth.org

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Samuel Brown, MD, MS, samuel.brown@imail.org

    Recruiting

  • Meharry Medical College

    Nashville, Tennessee, 37208

    Richard Freemont, MD, rfremont@mmc.edu

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Wesley H. Self, MD, 615.936.8047, wesley.self@vumc.org

    Lorraine Ware, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94305

    Angela Rogers, MD, ajrogers@stanford.edu

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Nuala Meyer, MD, MS, Nuala.Meyer@pennmedicine.upenn.edu

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Estelle Harris, MD, estelle.harris@hsc.utah.edu

    Recruiting

  • San Francisco General Hospital

    San Francisco, California, 94110

    Carolyn Hendrickson, MD, MPH, carolyn.hendrickson@ucsf.edu

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Carolyn Calfee, MD, carolyn.calfee@ucsf.edu

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Pratik Sinha, MBChB, PhD, p.sinha@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: The ARDS, Pneumonia, and Sepsis (APS) Consortium: A Prospective Observational Study to Evaluate Phenotypes

The goal of the observational APS phenotyping study is to better understand risk factors, potential biomarkers, length and severity of illness, and recovery for adults with ARDS, pneumonia, and/ or sepsis. This study will also generate a biobank of specimens collected from these patients that will be available to investigators for future studies of ARDS, sepsis, and/or pneumonia.

Read the detailed description

The APS phenotyping study will enroll hospitalized adult patients ≥18 years old who have or are at risk of developing ARDS, sepsis, or pneumonia. Participation in this study will involve collection of clinical data, completing questionnaires, and collection of samples such as blood, urine, and stool. Participants who are mechanically ventilated will also provide samples from their respiratory track. Data and samples will be collected both during and after hospitalization. Analyses to understand the mechanisms underlying ARDS, pneumonia, and sepsis will be conducted, with goals including the classification of patients with ARDS, pneumonia, and sepsis into biologically based phenotype categories and identifying new targets for future therapeutic trials.

Conditions
ARDS, Sepsis, Pneumonia
Being tested
Blood collection, Urine Collection, Nasal, oral, and rectal swabs, Stool collection, Heat Moisture Exchange Filter collection
Keywords
acute respiratory distress syndrome, sepsis, pneumonia, phenotype, endotype, critical illness
Medical subject headings
Sepsis, Pneumonia, Respiratory Distress Syndrome, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood collectionOther

    Blood will be collected from a catheter ("IV") that is already in place or using a needle stick into a vein.

    Blood will be collected in hospital (Cohorts A, B) and at visits 3 and 12 months following hospitalization for (Long-term Outcomes Cohort).

  • Urine CollectionOther

    Urine will be collected through a urinary catheter that is already in place or by urinating into a cup.

    Urine will be collected in hospital only (Cohorts A, B)

  • Nasal, oral, and rectal swabsOther

    Nasal, oral, and rectal swabs inserted into the nose, mouth, and rectum, respectively. The swabs will be rubbed inside the cavity and then removed the swab.

    Oral and nasal swabs will also be collected in hospital (Cohort A, B) and at visits 3 and 12 months following hospitalization for (Long-term Outcomes Cohort). Rectal swabs will be collected in hospital only (Cohorts A, B).

  • Stool collectionOther

    Stool will be collected either in a cup after defecation or by collecting it from a tube or bag that may already be in place that is catching stool.

    Stool will be collected in hospital (Cohorts A, B) and at visits 3 and 12 months following hospitalization (Long Term Outcomes Cohort).

  • Heat Moisture Exchange Filter collectionOther

    An HME filter is a sponge that is placed in the tubing between a patient and breathing machine. It reduces the amount of heat and moisture a patient loses when on a breathing machine. Moisture from breath is collected in this filter. The filter is changed every few hours. When the filter is changed, it will be saved to collect the moisture that it contains and run tests on it.

    HME filters will be collected in hospital on intubated patients only (Cohorts A, B).

  • Tracheal Aspirate sample collectionOther

    Patients on a breathing machine have a breathing tube in their trachea that connects their lungs to the breathing machine. A smaller tube, called a suction catheter, will be placed through the larger tube and fluid will be gently sucked out.

    Tracheal aspirate will be collected in hospital on intubated patients only (Cohorts A, B)

  • Non-bronchoscopic bronchoalveolar lavage (NBBAL)Procedure or surgery

    The NBBAL procedure involves putting a flexible rubber tube through the breathing tube into the airway of one of the lungs. A small amount of fluid is injected into the lung and then a gentle suction is used to collect fluid. Only patients who pass a safety screen showing that they are not at high risk for complications will have the NBBAL procedure performed.

    NBBAL will be performed in hospital on intubated patients only (Cohort A)

  • SurveysOther

    Participants will be contacted by email, text, and /or phone to give updates about their health. These surveys will ask questions about quality of life, mental health, return to work, and re-admission to the hospital. (Cohort A)

  • Short physical performance batteryOther

    At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort)

    Chair Stand Test: For this test the participant will sit in a chair. They will then stand as quickly as possible without using their upper body to assist them.

    Balance Test: For this test the participant will stand unsupported for 10 seconds with their feet in 3 different positions.

    4-meter walk: For this test the participant will walk 4 meters as quickly as possible.

  • Hand grip strengthOther

    At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort):

    The participant will squeeze a machine called a hand-held dynamometer 3 times with all their strength.

  • CNS Vital SignsOther

    At visits 3 and 12 months following hospitalization (Cohort A - Long-term Outcomes Cohort):

    The participant will sit at a computer and follow the prompts on the screen. This test takes about 45 minutes.

  • Muscle UltrasoundOther

    At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort):

    The participant will undergo ultrasound on the quadriceps muscle on the dominant side of their body.

  • Muscle StrengthOther

    At visits 3 and 12 months following hospitalization (Long-term Outcomes Cohort):

    A dynamometer will be used to measure muscle strength in the dominant leg.

  • SpirometryOther

    At a visit 12 months following hospitalization (Long-term Outcomes Cohort):

    The participant will have a clip placed on their nose and will be given a plastic mouthpiece that is connected to a machine called a spirometer. They will place their lips tightly around the mouthpiece and take in as big and deep of a breath as possible and then blow out as hard and fast as they can.

  • Lung Diffusion Testing (DLCO)Other

    At a visit 12 months following hospitalization (Long-term Outcomes Cohort):

    The participant will have a clip on their nose. They will put their mouth over a mouthpiece that is attached to a machine. This machine will deliver a small amount of carbon dioxide when they breathe in and will also record the results of the test. They will then take a few normal breaths. Next they will inhale deeply and exhale completely. They will breathe in quickly through their mouth and hold their breath for 10 seconds or as long as they can. Then they will breathe out.

  • Chest CT ScanRadiation

    At a visit 12 months following hospitalization (Long-term Outcomes Cohort):

    The participant will undergo a Chest Computed Tomography (CT) scan which uses special X-ray equipment to take detailed pictures of the lungs.

Study groups in NCT06521502
Study groupRoleWhat they receive
Cohort A (full study protocol - written informed consent)Cohort A is the cohort of APS study participants who have provided written informed consent for participation in the APS phenotyping study. Cohort A may participate in all study procedures in the APS phenotyping study.
Receives: Other: Blood collection; Other: Urine Collection; Other: Nasal, oral, and rectal swabs; Other: Stool collection; Other: Heat Moisture Exchange Filter collection; Other: Tracheal Aspirate sample collection; Procedure: Non-bronchoscopic bronchoalveolar lavage (NBBAL); Other: Surveys
Cohort B (alteration study protocol - alteration of informed consent)Cohort B is the cohort of APS study participants who are enrolled in the study under alteration of informed consent. Cohort B will participate in a modified set of procedures which omits procedures considered greater than minimal risk.
Receives: Other: Blood collection; Other: Urine Collection; Other: Nasal, oral, and rectal swabs; Other: Stool collection; Other: Heat Moisture Exchange Filter collection; Other: Tracheal Aspirate sample collection
Long-term Outcomes CohortThe Long-term Outcomes Cohort consists of a subset of participants with written informed consent for study participation (Cohort A) who complete in-person post-hospital study assessments. These in-person study visits are scheduled at 3- and 12-months after initial enrollment in the hospital. Interventions/exposures are denoted for this group for study procedures that are completed during an in-person post-hospital visit.
Receives: Other: Blood collection; Other: Nasal, oral, and rectal swabs; Other: Stool collection; Other: Short physical performance battery; Other: Hand grip strength; Other: CNS Vital Signs; Other: Muscle Ultrasound; Other: Muscle Strength; Other: Spirometry; Other: Lung Diffusion Testing (DLCO); Radiation: Chest CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ARDS, pneumonia, and sepsis classification

    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.

    Measured: Through day 7

Secondary outcomes (1)

  1. Death

    All-cause mortality

    Measured: 28 days, 3 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start25 Jul 2024
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521502
Sponsor's protocol ID
240088
Status last verified
Feb 2026
First submitted
16 Jul 2024
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: During conduct of the APS Consortium study procedures, data, biospecimens, and radiographic images will be collected by enrolling sites and transmitted to the APS Consortium Coordinating Center at Vanderbilt University Medical Center. Data and biospecimens will be organized and catalogued at the coordinating center. Additionally, the coordinating center will periodically transmit data and biospecimens to repositories managed by the National Heart, Lung, and Blood Institute (NHLBI) -- BioData Catalyst (data repository) and BioLINCC (biospecimen repository). During the period of performance for the APS Consortium, requests for data and/or biospecimens for use in ancillary studies will be reviewed for approval by the APS Steering Committee. After the completion of the APS Consortium period of performance, requests for data and/or biospecimens for use in ancillary studies will be governed by NHLBI through the BioData Catalyst and BioLINCC programs.

Publications

  • Semler MW, Bernard GR, Aaron SD, Angus DC, Biros MH, Brower RG, Calfee CS, Colantuoni EA, Ferguson ND, Gong MN, Hopkins RO, Hough CL, Iwashyna TJ, Levy BD, Martin TR, Matthay MA, Mizgerd JP, Moss M, Needham DM, Self WH, Seymour CW, Stapleton RD, Thompson BT, Wunderink RG, Aggarwal NR, Reineck LA. Identifying Clinical Research Priorities in Adult Pulmonary and Critical Care. NHLBI Working Group Report. Am J Respir Crit Care Med. 2020 Aug 15;202(4):511-523. doi: 10.1164/rccm.201908-1595WS.

    PubMed 32150460

  • Self WH, Calfee CS, Brown SM, Moss M, Ware LB, Hyzy RC, Meyer NJ, Reilly JP, Harhay MO, Shashaty MGS, Sandsmark DK, Auriemma CL, Jones TK, Prescott HC, Dickson RP, Nelson K, McSparron JI, Lagina M, Denstaedt SJ, Admon AJ, Patel BK, Wolfe KS, Hite RD, Hudock KM, Bastarache JA, Koyama T, Kerchberger VE, Ely EW, Jackson JC, Sinha P, Mudd PA, Kraft BD, Fremont RD, Singh R, Aggarwal NR, Jolley SE, Burnham EL, Mantelli RA, Janssen WJ, Moore CM, Douglas IS, Peterson R, Peltan ID, Barkauskas CE, Pratt EH, Harris ES, Scharfstein DO, Needham DM, Sahetya SK, Parker AM, Iwashyna TJ, Shenderov K, Matthay MA, Alipanah-Lechner N, Magee L, Shwartzman T, Lin C, Weingart MF, Langelier CR, Chao O, Hendrickson CM, Kornblith LZ, Chak S, Bardillon K, Rodriguez KH, Rogers AJ, Moore AR, Levitt JE, Vojnik R, Perez C, Lindsell CJ, Shotwell MS, Blette BS, Imhoff BW, Rice TW, Rhoads JP, Womack KN, Merkel AR, Ahmad LN, Zhao X, Grandon IE, Gong MN; ARDS, Pneumonia, and Sepsis Consortium. The ARDS, Pneumonia, and Sepsis Consortium: Rationale, Design, and Feasibility of a National Platform for Phenotyping Critical Illness Syndromes. Chest. 2026 Jul 13:S0012-3692(26)00959-1. doi: 10.1016/j.chest.2026.05.053. Online ahead of print.

    PubMed 42442528

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS and Sepsis, run by Vanderbilt University Medical Center at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wesley H. Self, MD, MPH (1-615-936-8047, wesley.self@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ARDS, pneumonia, and sepsis classification (time frame: Through day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06521502, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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