A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children

NCT ID: NCT05142813

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Infections; Sepsis; SIRS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Diagnostic Test: Blood specimen collection

Diagnostic Test: Blood specimen collection Study samples must be collected within before treatment with antibiotics or antivirals.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 90 Days
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Afliated Hospital of Southern University of Science and Technology

UNKNOWN

Sponsor Role: collaborator

mProbe Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Jia Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jia Huang

Role: PRINCIPAL_INVESTIGATOR

The Second Afliated Hospital of Southern University of Science and Technology

Central Contacts

James Schilling

Role: CONTACT

admin@mprobe.com

650479198

Other Identifiers

Sepsis_001

Identifier Type: -

Identifier Source: org_study_id