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

Completed

• Conditions: Infection

• Registration Number: NCT01746407
• Lead Sponsor: Abbott Diagnostics Division

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-11
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 872

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of infection to severe sepsis	72 hours	Assessment of the progression of infection to severe sepsis in an ED population who present with signs or symptoms of infection.

Trial Locations

Locations (2)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States