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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746407
First Posted: December 11, 2012
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Diagnostics Division
  Purpose
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
Infection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Plasma and serum samples stored @ -70C.

Enrollment: 872
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Presentation to an emergency department
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746407


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30303
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
  More Information

Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT01746407     History of Changes
Other Study ID Numbers: 09DELK12
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by Abbott Diagnostics Division:
Emergency Department
Infection
Sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes