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Completed

NCT Number: NCT03794284

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Non-Tuberculous Mycobacterial Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss
  • One or more sputum samples with positive AFB smear

Exclusion criteria

  • Receiving anti-mycobacterial treatment for more than one week
  • Refusal to consent

Treatment and study plan

VereMTB

Diagnostic Test

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.

Primary outcomes

  1. diagnostic test correlation

    Time frame: 6 months from the date of first recruitment

    Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2019
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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