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NCT06284187 Clinical Trial

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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06284187
Other study ID # KhonKaenH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source Khon Kaen Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers
Gender All
Age group 15 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Thananit Sangkomkamhang Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with pulmonary TB by Allplex™ MTB/MDRe Laboratory parameter From enrollment to the end of diagnosis at 1 week
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