Clinical trial NCT05142813: A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children
Official title: A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Sepsis
SIRS
Keywords: Acute infection
Fever without source
Viral infection
Lead sponsor: mProbe Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Second Afliated Hospital of Southern University of Science and Technology
First posted: 2021-12-03
Enrollment: 1100
Sex: ALL
Minimum age (years): 90
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of underlying cause of sepsis infection
timeFrame: 1 month
Secondary outcomes:
measure: Diagnosis of underlying cause of acute infection symptoms
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: The Second Afliated Hospital of Southern University of Science and Technology
name: Jia Huang
role: PRINCIPAL_INVESTIGATOR
References: