NCT04988984

Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)

Development of Device Kit for Rapid and Sensitive Diagnostic Method for the Tuberculosis; Using Amine Groups Called HI(Homobifunctional Imidoesters),Negative Charge of the Pathogen and Formed Electrical Bonding to Isolate and Concentrate the Pathogen

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: —

Summary

It is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized For patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using Xpert TB/RIF, additionally, diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using a new diagnostic method, and check the test results. Check whether the tuberculosis bacteria were actually cultured in the sample in the future, and compare the sensitivity and specificity in each test. Validation in animal model In an animal model (rat) with chronic obstructive pulmonary disease that shows similar characteristics to tuberculosis destructive lung, It will be investigated whether the HI method can be validated by separating and concentrating microbiome for various pathogens including Mycobacterium tuberculosis using HI method. Confirm.

Detailed description

Usefulness of Pulmonary Tuberculosis Diagnosis A comparison of the new diagnostic method with the Xpert TB/RIF test, which is widely used in clinical practice, that can quickly diagnose pulmonary tuberculosis within 1-2 days. ; Considering the sensitivity of the Xpert TB/RIF test as 70% and the sensitivity of the new diagnostic method as 90%, the number of patients with pulmonary tuberculosis required to confirm that the new diagnostic method is useful is estimated as 90 (study power 90%, alpha error = 0.05). And, if 200 patients with suspected pulmonary tuberculosis are registered, it is possible to verify the clinical usefulness compared to Xpert TB/RIF even in 60 AFB smear negative patients. In addition, for the same reason, if 150 additional patients who underwent bronchoscopy were enrolled, it would be possible to compare the diagnosis rate and utility of sputum and bronchoscopy fluid. Waiting for the tuberculosis bacteria culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis -Usefulness of extrapulmonary tuberculosis diagnosis Millet tuberculosis is disseminated tuberculosis through blood, and there are numerous millet-like lesions in the lungs, but in fact, the positive rate of AFB smear is low due to paucibacillary TB. It is planned to prove the usefulness of the new test method in 35 people with millet tuberculosis.

Conditions

• Tuberculosis Infection

Timeline

• Start date: 2020-11-17
• Primary completion: 2020-11-17
• Completion: 2023-12-31
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: South Korea