Sepsis Clinical Trial
Official title:
A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test
NCT number | NCT05142813 |
Other study ID # | Sepsis_001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2022 |
Est. completion date | December 2023 |
Verified date | March 2022 |
Source | mProbe Inc. |
Contact | James Schilling |
Phone | 650479198 |
admin[@]mprobe.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A case-control cohort study to develop and validate the performance of a whole blood gene expression test to distinguish sepsis infection from uninfected systemic inflammatory response syndrome cases in symptomatic adults and children without comorbidities.
Status | Not yet recruiting |
Enrollment | 1100 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 90 Days to 85 Years |
Eligibility | Criteria: Inclusion Criteria: - Clinical suspicion of an acute infectious disease - Presence of at least ONE of the following: 1. Temperature = 38°C or Temperature = 36°C 2. Heart rate > 90 bpm 3. Respiratory rate > 20/min 4. Self reported fever/chills - Symptom duration = 7 days Exclusion Criteria: - Received antibiotics or antivirals in the past 2 weeks. - Previous infection in previous 2 weeks - Primary or secondary immunodeficiency - Proven or suspected HIV, hepatitis B or hepatitis C infection - Current immune-suppressive or immune-modulating treatment - Active hematological malignancy - Other illnesses that affect life expectancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
mProbe Inc. | The Second Afliated Hospital of Southern University of Science and Technology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of underlying cause of sepsis infection | The sensitivity and specificity of the assay in differentiating bacterial from viral infection. | 1 month | |
Secondary | Diagnosis of underlying cause of acute infection symptoms | The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease. | 1 month |
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