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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04979767
Other study ID # STUDY#00145638
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date June 30, 2022

Study information

Verified date July 2021
Source University of Kansas Medical Center
Contact Luigi R Boccardi, BS
Phone 913-588-4022
Email lboccardi@kumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 30, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - = 50 years with = 2 chronic comorbidities - Highly suspected bacterial infection based on clinical or radiologic evidence - = 2 systemic inflammatory response syndrome (SIRS) criteria - Actual/anticipated admission to intensive care unit (ICU) - Anticipated length of hospital stay = 5 days Exclusion Criteria: - Pregnancy - Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (= 20 mg prednisone equivalents for = 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases) - Current immunotherapy use - Confirmed COVID-19 infection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28-day mortality All-cause mortality From enrollment to 28 days
Secondary Hospital mortality All-cause mortality From enrollment until hospital discharge, up to 90 days
Secondary 90-day mortality All-cause mortality From enrollment to 90 days
Secondary Length of stay Hospital length of stay From enrollment until hospital discharge, up to 90 days
Secondary Duration of infection Time to resolution of infection From enrollment until resolution of SIRS, up to 90 days
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