Procurement of Human Specimens for the Evaluation of Earl... | NCT01746407

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

NCT01746407

Sponsor

Abbott Diagnostics Division

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

872Actual

Phase

Not provided

Conditions

Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Dec 7, 2012

First Posted Date

Dec 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

872Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Presentation to an emergency department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greg S Martin, MD, M.Sc.	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Hospital		Atlanta	Georgia	30303	United States
Grady Memorial Hospital

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D004630	Emergencies
D018805	Sepsis

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided