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

This study is currently recruiting participants.
Verified April 2013 by Abbott Diagnostics Division
Sponsor:
Information provided by (Responsible Party):
Abbott Diagnostics Division
ClinicalTrials.gov Identifier:
NCT01746407
First received: December 7, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Abbott Diagnostics Division:

Primary Outcome Measures:
  • Progression of infection to severe sepsis [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 visit

Exclusion Criteria:

  • Previously enrolled in this study
  • Vulnerable individual
  • Unable to speak and/or understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746407

Contacts
Contact: Greg S Martin, MD, M.Sc 404-616-0148 greg.martin@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Greg S Martin, MD, M.Sc.     404-616-0148     greg.martin@emory.edu    
Sub-Investigator: Jonathan Sevransky, MD, MHS            
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Greg S Martin, MD     404-616-0148     greg.martin@emory.edu    
Principal Investigator: Greg S Martin, MD, M.Sc            
Sponsors and Collaborators
Abbott Diagnostics Division
Investigators
Principal Investigator: Greg S Martin, MD, M.Sc. Emory University
  More Information

No publications provided

Responsible Party: Abbott Diagnostics Division
ClinicalTrials.gov Identifier: NCT01746407     History of Changes
Other Study ID Numbers: 09DELK12
Study First Received: December 7, 2012
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Diagnostics Division:
Emergency Department
Infection
Sepsis

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

ClinicalTrials.gov processed this record on June 13, 2013