• Project status: Active

Research area: Clinical Sciences > Emergency

Doctor, child and parent

Biomarker discovery, verification, and validation for early sepsis diagnosis and risk stratification in children.

The Biomarkers in Sepsis (BASIS) study will identify new biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification in children.

These will have the potential to save lives through commercialisation into point-of-care tests.

The Biomarkers in Sepsis (BASIS) study will identify new biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification in children.

These will have the potential to save lives through commercialisation into point-of-care tests.

The Biomarkers in Sepsis (BASIS) study will identify new biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification in children.

These will have the potential to save lives through commercialisation into point-of-care tests.

About the study

Diagnosing sepsis early is challenging for clinicians because its symptoms are non-specific and often overlap with those of other mild, self-limiting infections.

Current diagnostic criteria for sepsis in children perform poorly, causing clinicians to rely on their own experience and judgement to diagnose sepsis. Clinicians must balance the risk of over-treatment, unnecessary hospitalisation, and overuse of broad-spectrum antibiotics with the risk of delayed treatment, which is a known contributor to poor outcomes and death from sepsis.

The lack of clear diagnostic criteria also results in variable estimates of sepsis prevalence, severity, outcomes and cost, plus difficulty benchmarking care and inconsistent enrolment strategies for clinical trials.

The Biomarkers in Sepsis (BASIS) study will identify new biomarkers (protein and mRNA) for early sepsis diagnosis and risk stratification in children. These will have the potential to save lives through commercialisation into point-of-care tests.

Information for participants

The BASIS study is being conducted at The Royal Children’s Hospital and will enrol 200 patients over 2 years.

There are no study-specific visits or procedures and participants will receive routine clinical care as per their treating clinicians.

Patients treated for suspected sepsis in the emergency department will have discarded samples from routine blood tests stored and frozen. Stored blood specimens will be analysed when the results of microbiological tests, disease course and outcomes are known.

The study will be divided into three phases:

  1. Discovery phase: New candidate biomarkers will be identified based on their association with confirmed sepsis diagnosis and severity of illness
  2. Verification phase: Candidate biomarkers will be matched with the potential for commercially viable point-of-care testing
  3. Validation phase: Verified sepsis biomarkers will be validated using age and gender-matched samples from healthy children

Due to the time-critical nature of sample storage, we have a waiver of consent to store discarded blood samples and will obtain informed consent for biomarker analysis of stored samples.

Research team

Lead researcher

Project members

Funding and collaborators

The BASIS study is a collaboration between The Royal Children’s Hospital Emergency Research, Haematology Research, and the Walter and Elisa Hall Institute (WEHI).

Funding

Collaborators

    Contact us

    Biomarkers in Sepsis (BASIS)
    Murdoch Children's Research Institute
    The Royal Children's Hospital
    50 Flemington Road
    Parkville VIC 3052
    Australia
    Email: [email protected]

    child in hospital

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