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

Fudan University

Status: Unknown

Conditions: Tuberculosis, Pulmonary

Treatments: Diagnostic Test: CRISPR-based Test

Study type: Observational

Funder types: Other

Identifiers

NCT04074369

20190601

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

Pulmonary Tuberculosis Suspects

Description:

Individuals with suspected TB infection

Treatment:

Diagnostic Test: CRISPR-based Test