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NCT01746407 Clinical Trial

Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis

Infection Clinical Trial

— EMOS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01746407
Other study ID # 09DELK12
Secondary ID
Status Completed
Phase N/A
First received December 7, 2012
Last updated December 28, 2015
Start date December 2012
Est. completion date December 2014

Study information
Verified date December 2015
Source Abbott Diagnostics Division
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 872
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Abbott Diagnostics Division

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression of infection to severe sepsis Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection. 72 hours No
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