InfectionsNCT05142813
A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children
An observational study of Infections and Sepsis, run by mProbe Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 90 days to 85 years
- Conditions the study is for
- Infections, Sepsis, SIRS
- What is being tested?
- Diagnostic Test: Blood specimen collection
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 90 days to 85 years
- All sexes
- Child, Adult, Older adult
Study population: Eligible participants 90 days of age and older that visit the hospital or emergency department with a suspected acute infection.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Diagnostic Test: Blood specimen collection
- Keywords
- Acute infection, Fever without source, Viral infection
- Medical subject headings
- Infections, Sepsis, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Blood specimen collectionDiagnostic test
Diagnostic Test: Blood specimen collection Study samples must be collected within before treatment with antibiotics or antivirals.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of underlying cause of sepsis infection
The sensitivity and specificity of the assay in differentiating bacterial from viral infection.
Measured: 1 month
Secondary outcomes (1)
Diagnosis of underlying cause of acute infection symptoms
The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startMay 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mProbe Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Afliated Hospital of Southern University of Science and Technology
- Responsible party
- Principal investigator, Jia Huang, mProbe Inc.
- Investigators
- Jia Huang, Principal investigator, The Second Afliated Hospital of Southern University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142813
- Sponsor's protocol ID
- Sepsis_001
- Status last verified
- Mar 2022
- First submitted
- 19 Nov 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test
- ClinicalTrials.gov ID
- NCT05142813
- Acronym / sponsor ID
- Sepsis_001
- Conditions
- Infections, Sepsis, SIRS
- Keywords
- Acute infection, Fever without source, Viral infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- mProbe Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Second Afliated Hospital of Southern University of Science and Technology
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 90 days to 85 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible participants 90 days of age and older that visit the hospital or emergency department with a suspected acute infection.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Blood specimen collectionDiagnostic Test: Blood specimen collection Study samples must be collected within before treatment with antibiotics or antivirals. | Diagnostic test | – |
Primary outcome
Diagnosis of underlying cause of sepsis infection
Time frame: 1 month
The sensitivity and specificity of the assay in differentiating bacterial from viral infection.
1 secondary outcome
Diagnosis of underlying cause of acute infection symptoms
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Huang principal investigator
The Second Afliated Hospital of Southern University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Infections and Sepsis, run by mProbe Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Schilling (650479198, admin@mprobe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of underlying cause of sepsis infection (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.