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

• Conditions: Tuberculosis, Pulmonary
• Interventions: Diagnostic Test: CRISPR-based Test

• 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

Study Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-28
• Last Update Submitted: 2019-08-28
• Study First Posted: 2019-08-30
• Last Update Posted: 2019-08-30
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30

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

Arm && Interventions

Group	Intervention	Description
Pulmonary Tuberculosis Suspects	CRISPR-based Test	Individuals with suspected TB infection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China