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Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects

Conditions
Tuberculosis, Pulmonary
Registration Number
NCT04074369
Lead Sponsor
Huashan Hospital
Brief Summary

This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
800
Inclusion Criteria
  • Suspected pulmonary TB.
  • Ability and willingness of candidate or legal guardian/representative to provide informed consent.
  • Men and women age equal to or greater than 18 years.
Exclusion Criteria
  • Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.week 0
Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis.week 0
Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis.week 0
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Huashan Hospital

🇨🇳

Shanghai, Shanghai, China

Huashan Hospital
🇨🇳Shanghai, Shanghai, China
Jing-wen Ai
Contact
(+86) 21 5288 7970
jingwenai1990@126.com
Xian Zhou
Contact
(+86) 21 5288 7970
zhouxianhz@gmail.com

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