Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating biomarkers for infection and inflammation in sepsis

Official title: Early Detection of Inflammatory Biomarkers in Infection

Run by Beth Israel Deaconess Medical Center · NCT02545478 · Data updated 2026-11-12

This study is testing new blood markers to see if they can help doctors identify patients with sepsis who are at risk for serious problems, so they can provide better care.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment4200 (estimated)
SponsorBeth Israel Deaconess Medical Center
Academic / other
Drugs / interventionsradiation
Locations2 sites (Boston, Massachusetts and 1 other locations)
StatusRecruiting
StartedApril 2006
Main results expectedDecember 2030
Study endsDecember 2031
Registry record updatedApril 15, 2026
Trial IDNCT02545478 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with confirmed or suspected infections.

Probably not a fit

Patients with non-infectious clinical presentations or those who are suspected of having an infection may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigation aims to assess the effectiveness of early biomarkers in identifying patients at risk for poor outcomes in sepsis and septic shock. It focuses on the body's immune response and inflammatory markers that may indicate the severity of infection. Current laboratory parameters like white blood cell count and CRP are commonly used but are not always reliable, prompting the need for better predictive tests. By understanding the host response to infection, the study seeks to improve patient management and treatment strategies.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and treatment of sepsis, potentially saving lives.

How similar studies have gone: Other studies have explored biomarkers in sepsis, but this approach may provide novel insights into early detection and management.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for Infected subjects:

* Age 18 years of age or older
* Confirmed or suspected infection

Inclusion Criteria for Control Subjects:

* 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

Exclusion Criteria for Control Subjects:

\- Suspected infection

Where it's running

  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.