跳至主要内容
临床试验/CTRI/2018/12/016579
CTRI/2018/12/016579尚未招募不适用

Quantification of Immune Cell Types and Identification of Cell-Type Specific Biomarker Expression in Pulmonary and Extra-Pulmonary Tuberculosis Patients: a pilot study

Public Health England1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
This study will determine immune cell type profiles and specific biomarker expression patterns for various cell-types in PTB and EPTB, as well as in pneumonia (positive lung infection disease control (e.g. H. influenzae and S. pneumoniae) and healthy controls

研究概览

简要总结

Tuberculosis(TB) presents a serious healthcare crisis. In high burden, low resource countries, poorhealthcare access, high cost, and laboratorydependence inhibits testing, leading to delays in diagnosis, increasingtransmission and disease severity.  Developmentof affordable, sensitive and rapid diagnostictools for diagnosis of TB may play a vital role in resource-poorsettings, where the incidence of disease is high. The present study may revealthe expression patterns and/or validity of host biomarkers in whole blood ofpatients with PTB, EPTB, as well as in healthy controls, which may informdiagnostic test development. Development of host biomarker-based TB diagnostickits may help clinicians to diagnose and monitor onset and progression ofdisease at an earlier stage and provide solutions where existing diagnosticoptions are inadequate. TB diagnostic kits developed from the output of the present study willimprove both early diagnosis/triage and patient stratification and will be costeffective and specific. They may be considered an alternative for currentdiagnostic tests such as IGRA which lack sensitivity and are inadequateand/or expensive.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Group 1: All geneXpert positive newly diagnosed treatment naive adult patients (>18 years of age) with pulmonary tuberculosis diagnosed at the Microbiology department Group 2: All geneXpert positive newly diagnosed treatment naive adult patients (>18 years of age) with extra pulmonary tuberculosis diagnosed at the Microbiology department Group 3: Bacteriologically confirmed cases of Pneumonia.
  • •Group 4: Healthy volunteers who are negative for Tuberculin Skin Test or Interferon Gamma Release Assay (to rule out latent TB).

排除标准

  • •HIV positive Patients on steroids or other immunosuppressive drugs Pregnant women.

结局指标

主要结局

This study will determine immune cell type profiles and specific biomarker expression patterns for various cell-types in PTB and EPTB, as well as in pneumonia (positive lung infection disease control (e.g. H. influenzae and S. pneumoniae) and healthy controls

时间窗: 2 years

次要结局

  • The development of host biomarkers based TB diagnostic kits may help clinicians to screen for, diagnose and follow the progression of TB at an earlier stage(5 years)

研究者

申办方类型
Research institution

研究点 (1)

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