Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Abbott Diagnostics Division Identifier:
First received: December 7, 2012
Last updated: September 23, 2014
Last verified: September 2014

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 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 ] [ 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: 950
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01746407

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

No publications provided

Responsible Party: Abbott Diagnostics Division Identifier: NCT01746407     History of Changes
Other Study ID Numbers: 09DELK12
Study First Received: December 7, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Diagnostics Division:
Emergency Department
Sepsis processed this record on March 03, 2015