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EMOS: Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis

Sponsor
Abbott Diagnostics Division (Industry)
Overall Status
Completed
CT.gov ID
NCT01746407
Collaborator
(none)
872
Enrollment
2
Locations
24
Duration (Months)
436
Patients Per Site
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis. The samples will be used for research and development activities related to sepsis, infections, etc.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    872 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Procure Human Specimens for Use in the Diagnosis and Management of Sepsis and Other Related Conditions
    Study Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Progression of infection to severe sepsis [72 hours]

      Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 yrs of age or older

    • For women of child bearing years: not known to be pregnant

    • Blood culture ordered as part of the ED, ICU (or equivalent) or hospital floor stay.

    Exclusion Criteria:

    • Previously enrolled in this study

    • Vulnerable individual

    • Unable to speak and/or understand English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30303
    2 Grady Memorial Hospital Atlanta Georgia United States 30303

    Sponsors and Collaborators

    • Abbott Diagnostics Division

    Investigators

    • Principal Investigator: Greg S Martin, MD, M.Sc., Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Diagnostics Division
    ClinicalTrials.gov Identifier:
    NCT01746407
    Other Study ID Numbers:
    • 09DELK12
    First Posted:
    Dec 11, 2012
    Last Update Posted:
    Dec 30, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Abbott Diagnostics Division
    Emergency Department
    Infection
    Sepsis
    Additional relevant MeSH terms:
    Sepsis

    Study Results

    No Results Posted as of Dec 30, 2015