Recruiting

Sepsis Biomarkers

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT02545478

Conditions

Sepsis

Infection

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Sepsis

Infection

Inflammation

Study ID

NCT02545478

Start date

Apr, 2006

Status verified date

Apr, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

4200 participants

Anticipated

Interventions and Outcome Measures

Arms

Infected Group

subjects with suspected infection

Non-infected group

subjects without any infection

Primary outcome measure

  • 28 day in-hospital mortality [ Time Frame: within 28 days after inclusion ]

Central Contacts and Locations

Central contacts

Nathan Shapiro, MD MPH

617-754-2343nshapiro@bidmc.harvard.edu

Carlo Ottanelli, BSc

617-650-0042cottanel@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nathan Shapiro, MD MPH

617-754-2343nshapiro@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • septic shock
  • infection
  • inflammation
  • pathologic process
  • biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-15.