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NCT06838780Active, not recruiting

Host Response to Infection by Direct Analysis of Leukocyte Single Cell-type Gene Expression/transcript Abundance, Direct LS-TA

Peripheral Blood Single Cell-type Expression Profile of Interferon-stimulated and Other Biomarker Genes for Triage of Febrile Patients

Source: ClinicalTrials.gov · Last updated 3 Mar 2025

Brief summary (registry, in English)

Febrile illness is a common condition, particularly among young patients and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Most diagnostic tests are targeted towards the detection of pathogens while other assays are mostly related to serum proteins. Blood cells transcriptome has been explored to differentiate bacterial and viral infections. Here, we propose to develop a rapid test using the host responses in terms of gene expressions of single-cell populations of peripheral leukocytes (monocytes and granulocytes) to differentiate three major categories of infections that are bacterial, viral, and tuberculosis. The assay is called Direct leukocyte single cell-type transcript abundance (TA) assay (DIRECT LS-TA) as it can directly determine the gene expression of a specified single cell-type (e.g. monocytes and granulocytes) among various leukocyte cell populations directly in a peripheral blood sample. Such results signify the nature of host response and can be used to indicate the type of infection (viral, bacterial or active tuberculosis).

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
192 (actual)
First submitted
17 Feb 2025
Start date
1 Jan 2018
Primary completion date
1 Jan 2026
Lead sponsor
Chinese University of Hong Kong
Diseases
Tuberculosis
NCT number
NCT06838780

What you commit to

  • Study type: Observational
  • Participants enrolled: 192
  • From 1 Jan 2018 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • End stage renal failure
  • Infections for which long term antibiotic treatment is strongly recommended (including infective endocarditis, osteoarticular infections, cerebral or hepatic or lung abscesses, tuberculosis or nontuberculous mycobacterial infections)

Other

  • Pregnancy

Who the study is looking for

  • Bacterial infection sample: positive isolation of organism in blood culture (Bacterial infection sample group)
  • Clinical diagnosed active TB (Tuberculosis infection group)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dept of Chemical Pathology, Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.