Tuberculosis, Pulmonary Clinical Trial
Official title:
Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects
NCT number | NCT04074369 |
Other study ID # | 20190601 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | October 30, 2019 |
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital | Hangzhou Red Cross Hospital, Wenzhou Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | ||
Primary | Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. | week 0 |
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