Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis (EMOS)

December 28, 2015 updated by: Abbott Diagnostics Division

Observational Study to Procure Human Specimens for Use in the Diagnosis and Management of Sepsis and Other Related Conditions

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

872

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Atlanta, Georgia, United States, 30303
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Presentation to an emergency department

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of infection to severe sepsis
Time Frame: 72 hours
Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diagnostics Division

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09DELK12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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