- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05142813
A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children
A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: James Schilling
- Telefonnummer: 650479198
- E-post: admin@mprobe.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Criteria: Inclusion Criteria:
- 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
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Diagnosis of underlying cause of sepsis infection
Tidsramme: 1 month
|
The sensitivity and specificity of the assay in differentiating bacterial from viral infection.
|
1 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Diagnosis of underlying cause of acute infection symptoms
Tidsramme: 1 month
|
The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease.
|
1 month
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jia Huang, The Second Afliated Hospital of Southern University of Science and Technology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Sepsis_001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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