NCT05142813

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

November 19, 2021

Last Update Submit

March 25, 2022

Conditions

InfectionsSepsisSIRS

Keywords

Acute infectionFever without sourceViral infection

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of underlying cause of sepsis infection

    The sensitivity and specificity of the assay in differentiating bacterial from viral infection.

    1 month

Secondary Outcomes (1)

  • Diagnosis of underlying cause of acute infection symptoms

    1 month

Interventions

Diagnostic Test: Blood specimen collectionDIAGNOSTIC_TEST

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

Eligibility Criteria

Age90 Days - 85 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical suspicion of an acute infectious disease
  • Presence of at least ONE of the following:
  • Temperature ≥ 38°C or Temperature ≤ 36°C
  • Heart rate \> 90 bpm
  • Respiratory rate \> 20/min
  • Self reported fever/chills
  • Symptom duration ≤ 7 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

InfectionsSepsisVirus Diseases

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jia Huang

    The Second Afliated Hospital of Southern University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Schilling

CONTACT

650479198admin@mprobe.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 3, 2021

Study Start

May 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03