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OpenTrials
Completed

NCT Number: NCT06284187

Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis

BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.

OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Pulmonary Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis, Pulmonary

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thananit Sangkomkamhang

Khon Kaen, 40000, Thailand

About this study

A retrospective study design of adult patients (> 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.

Who can participate

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

Inclusion criteria

  • Clinical suspected pulmonary M. tuberculosis infection
  • Aged 15 years and older

Exclusion criteria

  • Children under 15 years old
  • Non-tuberculous mycobacteria (NTM) detection

Treatment and study plan

Primary outcomes

  1. Number of participants with pulmonary TB by Allplex™ MTB/MDRe

    Time frame: From enrollment to the end of diagnosis at 1 week

    Laboratory parameter

Sponsors and collaborators

Lead sponsor

Khon Kaen Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

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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