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

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074369
• Other study ID #: 20190601
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2019
• Source: Huashan Hospital
• Contact: Wenhong Zhang
• Phone: (+86) 21 5288 7970
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• CRISPR-based Test
CRISPR-based Test performed on sputum or BALF in TB suspects.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Huashan Hospital	Hangzhou Red Cross Hospital, Wenzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

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