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The APS Phenotyping Study
N/A
Recruiting
Led By Wesley H. Self, MD, MPH
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months
Awards & highlights
No Placebo-Only Group
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. 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.
Eligible Conditions
- Pneumonia
- Umbilical Sepsis
- Sepsis
- Acute Respiratory Distress Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ARDS, pneumonia, and sepsis classification
Secondary study objectives
Death
Other study objectives
Acute kidney injury (AKI)
Central Nervous System (CNS) vital signs score
Clinical frailty scale
+25 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Long-term Outcomes CohortExperimental Treatment11 Interventions
The 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-, 6-, 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.
Group II: Cohort B (alteration study protocol - alteration of informed consent)Experimental Treatment6 Interventions
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.
Group III: Cohort A (full study protocol - written informed consent)Experimental Treatment8 Interventions
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.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
908 Previous Clinical Trials
930,840 Total Patients Enrolled
4 Trials studying Pneumonia
1,823 Patients Enrolled for Pneumonia
Wesley H. Self, MD, MPHPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
14,889 Total Patients Enrolled