NCT01746407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
872

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

December 7, 2012

Last Update Submit

December 28, 2015

Conditions

Infection

Keywords

Emergency DepartmentInfectionSepsis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Presentation to an emergency department

You may qualify if:

  • 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.

You may not qualify if:

  • Previously enrolled in this study
  • Vulnerable individual
  • Unable to speak and/or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30303, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples stored @ -70C.

MeSH Terms

Conditions

InfectionsEmergenciesSepsis

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeInflammation

Study Officials

  • Greg S Martin, MD, M.Sc.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

US(2)