NCT03794284

Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

Detailed description

Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment. This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

Conditions

• Tuberculosis
• Non-Tuberculous Mycobacterial Pneumonia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VereMTB	At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.

Timeline

• Start date: 2019-02-28
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2019-01-07
• Last updated: 2022-08-09

Locations

1 site across 1 country: Hong Kong