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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4200 (estimated) |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | April 2006 |
| Main results expected | December 2030 |
| Study ends | December 2031 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT02545478 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
- Principal investigator: Nathan Shapiro, MD MPH — Beth Israel Deaconess Medical Center
- Study coordinator: Nathan Shapiro, MD MPH
- Email: nshapiro@bidmc.harvard.edu
- Phone: 617-754-2343
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care
This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.
-
Early detection of sepsis-related blood clotting problems in severe burn patients
This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.
-
Neutrophil EMR3 as a biomarker for sepsis in ICU patients
Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.
-
Thymalfasin added to standard care for adults with sepsis and immune dysfunction
This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.
-
Multicenter group study of sepsis and ARDS in China
This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.
-
Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.