A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children

A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infections; Sepsis; SIRS
• Intervention / Treatment: Diagnostic test: Diagnostic Test: Blood specimen collection

Detailed Description

The purpose of this prospective, non-interventional study is to develop and validate a blood gene expression test for diagnosing the cause of sepsis in adults and children with symptoms of infection.

Sepsis affects 31.5 million people globally leading to 5.3 million deaths each year. Sepsis is particularly harmful to immunodeficient patients undergoing cancer therapy with 3.7 percent to 6.4 percent of cancer patients diagnosed with sepsis in the US in their first year after cancer diagnosis. Current tests to diagnose the infectious cause of sepsis rely on blood cultures which takes 24-48 hours to complete; leading to delays in early treatment critical to reduce the risk of developing sepsis shock and possibly death. In addition, around 50 percent of severe sepsis cases are culture negative, confounded acute infections not detected in the blood, by viral infection or uninfected patients exhibiting systemic inflammatory response syndrome (SIRS). Since sepsis often progresses to sepsis shock within 72 hours, suspected sepsis cases are usually immediately treated with antibiotics until results from testing distinguish the cause of symptoms. This leads to the over-use of antibiotics and delays appropriate treatment for those without bacterial infection or un-infected SIRS.

A quick and accurate diagnostic blood test may enable early discrimination of the cause of sepsis resulting in faster more appropriate treatments and reduced sepsis complications and death.

The study will collect blood samples from participants presenting symptoms of acute infection, without co-morbidities and follow symptom severity and mortality for 28 days.

• Study Type: Observational
• Enrollment (Anticipated): 1100

Contacts and Locations

• Study Contact: Name: James Schilling; Phone Number: 650479198; Email: admin@mprobe.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants 90 days of age and older that visit the hospital or emergency department with a suspected acute infection.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of underlying cause of sepsis infection	The sensitivity and specificity of the assay in differentiating bacterial from viral infection.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of underlying cause of acute infection symptoms	The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease.	1 month

Collaborators and Investigators

• Sponsor: mProbe Inc.
• Collaborators: The Second Afliated Hospital of Southern University of Science and Technology
• Investigators: Principal Investigator: Jia Huang, The Second Afliated Hospital of Southern University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Viral infection; Fever without source; Acute infection
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Infections
• Other Study ID Numbers: Sepsis_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No