An observational study in Tuberculosis and Non-Tuberculous Mycobacterial Pneumonia, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 46 is below the median of 240 across 427 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients admitted to the Prince of Wales Hospital with suspected pulmonary TB with positive AFB smears will be identified by Infectious Diseases physicians and recruited accordingly.
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Exclusion Criteria:
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.
diagnostic test correlation
Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM
Time frame: 6 months from the date of first recruitment
Plan to share: No
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →