A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children

• Conditions: Infections; SIRS; Sepsis

• Registration Number: NCT05142813
• Lead Sponsor: mProbe Inc.

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-03-29
• Study Start: 2022-05
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of underlying cause of sepsis infection	1 month	The sensitivity and specificity of the assay in differentiating bacterial from viral infection.

Secondary Outcome Measures

Name	Time	Method
Diagnosis of underlying cause of acute infection symptoms	1 month	The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease.