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NCT04261621 · ClinicalTrials.gov registry record
Early Identification of SEPsis SIGNs in Emergency Department
A clinical trial of Sepsis and Infection, sponsored by BioMérieux.
- Completed
- Registry status
- 815
- Enrollment target
- 12
- Study locations
NCT04261621: Completed study of Sepsis and Infection, sponsored by BioMérieux.
NCT04261621 is a study of Sepsis and Infection that has completed, run by BioMérieux. The registered enrollment target is 815 participants, below the 6,556-participant average among 90 other Sepsis trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04261621, a study of Sepsis and Infection, has completed, sponsored by BioMérieux.
- COMPLETED
- Registry status
- 815 participants
- Enrollment target
- 12
- Study locations
Study Summary
Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.
Primary Outcome
clinical deterioration of a patient at any time during the 72-hour period following T0 (enrollment), which is defined as any of the following: * increase of SOFA score ≥ 2 points * need of new organ support (respiratory, circulatory, renal) * death An Endpoint Adjudication Committee (EAC) composed of acute care specialists will apply these criteria. This EAC will also confirm /exclude the presence of infection at T0 (enrollment) based on all information available in eCRF.
Study Locations (12)
Other
- CH Henri Mondor Aurillac - Aurillac
- CHU Grenoble alpes - La Tronche
- CHU Dupuytren - Limoges
- Hopital Edouard Herriot, HCL - Lyon
- CH de Montauban - Montauban
- Hôpital Saint-Antoine AP-HP - Paris
- Hôpital Trousseau CHRU - Tours
- Centre Hospitalier Princesse Grace - Monaco
Colorado
- University of Colorado School of Medicine - Aurora
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Tennessee
- Vanderbilt University Medical Center - Nashville
Washington
- University of Washington Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 815 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2022-05-02 |
What the finished NCT04261621 record still lists
NCT04261621 is an observational study that tracks outcomes without assigning an intervention. The registered 815 participants enrollment target is mid-sized for trials with a published cap, below the 6,556-participant average among 90 other Sepsis trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Sepsis appearing as the primary indexed condition, and to 0 interventions.
NCT04261621 lists 12 locations in 5 states (Other, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04261621 about?
NCT04261621 is a clinical study titled "Early Identification of SEPsis SIGNs in Emergency Department". Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.
What is the current status of trial NCT04261621?
This trial is currently completed. The enrollment target is 815 participants. The study started on 2020-07-06. Estimated completion is 2022-05-02.
What conditions does trial NCT04261621 study?
This clinical trial studies the following conditions: Sepsis, Infection.
Who is sponsoring clinical trial NCT04261621?
This trial is sponsored by BioMérieux, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04261621 being conducted?
This trial has 12 study locations across Colorado, Massachusetts, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04261621's enrollment target sits among peer trials
815 20th of 90 higher than 71 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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