Biomarkers in Infection
Early Detection of Inflammatory Biomarkers in Infection
1 other identifier
observational
4,200
1 country
2
Brief Summary
The purpose of this investigation is to evaluate how early biomarkers of infection and inflammation perform in identifying patients at risk for poor outcome in sepsis and septic shock.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
April 15, 2026
April 1, 2026
24.7 years
September 8, 2015
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28 day in-hospital mortality
participants will be followed up for 28 days
within 28 days after inclusion
Secondary Outcomes (1)
Organ Dysfunction assessed by Sepsis-related Organ Failure Assessment (SOFA) Score
within 24 hours
Study Arms (2)
Infected Group
subjects with suspected infection
Non-infected group
subjects without any infection
Eligibility Criteria
Patients presenting to the Emergency Department with suspected infection as well as a non-infected control population.
You may qualify if:
- Age 18 years of age or older
- Confirmed or suspected infection
- Age 18 years of age or older
- A non-infectious clinical presentation to include
- Normal white blood cell count ( \> 4,000 and/or \< 12,000)
- Normothermia ( \> 96.5 and/or less 100.4)
- Absence of the following clinical complaints: productive cough, fever, pyuria, rash
- No evidence of acute coronary syndrome
You may not qualify if:
- \- Suspected infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Biospecimen
whole blood, serum and plasma, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Shapiro, MD MPH
Beth Israel Deaconess Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Emergency Medicine
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 10, 2015
Study Start
April 1, 2006
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2031
Last Updated
April 15, 2026
Record last verified: 2026-04