Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Huashan Hospital
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.
Time Frame: 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.
Time Frame: 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.
Time Frame: week 0
Secondary Outcomes
No secondary outcomes reported
Investigators
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital