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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 18, 2013
Last verified: December 2013
  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 ] [ 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: July 2014
Estimated Primary Completion Date: July 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, 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 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: December 18, 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 July 22, 2014