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

NCT06284187 | Completed

• 1 other identifier: KhonKaenH
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis; Pulmonary

Keywords

pulmonary tuberculosis; real-time PCR; diagnosis test

Outcome Measures

Primary Outcomes (1)

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

  Laboratory parameter

  From enrollment to the end of diagnosis at 1 week

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

out patients clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen Hospital: lead

Study Sites (1)

Thananit Sangkomkamhang

Khon Kaen, 40000, Thailand

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kriengsak Vacharanukulkieti, Medicine

  Khon Kaen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hospital

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TH (1)