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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

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